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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94583

81 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 08, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

81 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 81

Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;

Z-2981-2024
Recall number
Z-2981-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDA1894, Lot Number 2019080890; DYNDA1894, Lot Number 2019082190; MNS9580, Lot Number 2019080890

Distribution pattern

Worldwide distribution.

device · product 2 of 81

Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DYND300015P; 5) Flexible LMA Pack with Syringe and Lube, Size 2, Pack Number DYND300020P; 6) Flexible LMA Pack with Syringe and Lube, Size 2.5, Pack Number DYND300025P; 7) Flexible LMA Pack with Syringe and Lube, Size 3, Pack Number DYND300030P; 8) Flexible LMA Pack with Syringe and Lube, Size 4, Pack Number DYND300040P; 9) Flexible LMA Pack with Syringe and Lube, Size 5, Pack Number DYND300050P; 10) TRACHEOSTOMY TRAY , Pack Number DYNDJ1061A ; 11) TRACHEOSTOMY , Pack Number DYNJ45495F

Z-2982-2024
Recall number
Z-2982-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS983142B , Lot Number 19DBQ261 ; CDS983142B , Lot Number 19FBD886 ; CDS983142B , Lot Number 19KBJ083 ; CDS984376B , Lot Number 21HBJ875 ; CDS984376B , Lot Number 21JBJ731 ; CDS984376B , Lot Number 22DBM097 ; CDS984376B , Lot Number 22EBK349 ; CDS984376B , Lot Number 19EBI656 ; CDS984376B , Lot Number 22HBS594 ; CDS984376B , Lot Number 19SBG293 ; CDS984376B , Lot Number 19IBF800 ; CDS984376B , Lot Number 22LBA281 ; CDS984376B , Lot Number 23ABC499 ; CDS984376B , Lot Number 23ABE884 ; CDS984376B , Lot Number 19VBG331 ; CDS984376B , Lot Number 23BBS463 ; CDS984376B , Lot Number 20DBF949 ; CDS984376B , Lot Number 20EBU288 ; CDS984376B , Lot Number 20HBP449 ; CDS984376B , Lot Number 20IBM472 ; CDS984376B , Lot Number 21ABF587 ; DYND300010P, Lot Number 59220061157; DYND300010P, Lot Number 59220122559; DYND300010P, Lot Number 59221040752; DYND300010P, Lot Number 59221071480; DYND300010P, Lot Number 59222030363; DYND300010P, Lot Number 59222051032; DYND300010P, Lot Number 59222061222; DYND300010P, Lot Number 59222040781; DYND300010P, Lot Number 59222040997; DYND300010P, Lot Number 59222071481; DYND300010P, Lot Number 59222071537; DYND300015P, Lot Number 59220061157; DYND300015P, Lot Number 59220122559; DYND300015P, Lot Number 59221040651; DYND300015P, Lot Number 59221050988; DYND300015P, Lot Number 59221091941; DYND300015P, Lot Number 59222051078; DYND300015P, Lot Number 59222051032; DYND300015P, Lot Number 59222081778; DYND300015P, Lot Number 59222081923; DYND300020P, Lot Number 59220061157; DYND300020P, Lot Number 59221030489; DYND300020P, Lot Number 59221061255; DYND300020P, Lot Number 59221102224; DYND300020P, Lot Number 59221112515; DYND300020P, Lot Number 59221122696; DYND300020P, Lot Number 59222040997; DYND300020P, Lot Number 59222051032; DYND300020P, Lot Number 59222061222; DYND300020P, Lot Number 59222071643; DYND300020P, Lot Number 59222081908; DYND300020P, Lot Number 59222040781; DYND300020P, Lot Number 59222071481; DYND300020P, Lot Number 59222081778; DYND300020P, Lot Number 59222081923; DYND300025P, Lot Number 59220061157; DYND300025P, Lot Number 59221030489; DYND300025P, Lot Number 59221061255; DYND300025P, Lot Number 59221071480; DYND300025P, Lot Number 59222051032; DYND300025P, Lot Number 59222061222; DYND300025P, Lot Number 59222081908; DYND300025P, Lot Number 59222081778; DYND300025P, Lot Number 59222081923; DYND300030P, Lot Number 59220061157; DYND300030P, Lot Number 59221020196; DYND300030P, Lot Number 59221030489; DYND300030P, Lot Number 59221040752; DYND300030P, Lot Number 59221081720; DYND300030P, Lot Number 59222010094; DYND300030P, Lot Number 59222010145; DYND300030P, Lot Number 59222030363; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222051032; DYND300030P, Lot Number 59222061222; DYND300030P, Lot Number 59222071481; DYND300030P, Lot Number 59222071690; DYND300030P, Lot Number 59222081778; DYND300030P, Lot Number 59222081923; DYND300040P, Lot Number 59220061157; DYND300040P, Lot Number 59220122896; DYND300040P, Lot Number 59221030489; DYND300040P, Lot Number 59221050956; DYND300040P, Lot Number 59221061255; DYND300040P, Lot Number 59221061366; DYND300040P, Lot Number 59221071370; DYND300040P, Lot Number 59221071480; DYND300040P, Lot Number 59221071620; DYND300040P, Lot Number 59221050960; DYND300040P, Lot Number 59221061193; DYND300040P, Lot Number 59221081720; DYND300040P, Lot Number 59221102224; DYND300040P, Lot Number 59221112515; DYND300040P, Lot Number 59221112403; DYND300040P, Lot Number 59221122696; DYND300040P, Lot Number 59222030363; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222061222; DYND300040P, Lot Number 59222040781; DYND300040P, Lot Number 59222040923; DYND300040P, Lot Number 59222071481; DYND300040P, Lot Number 59222071690; DYND300040P, Lot Number 59222081778; DYND300040P, Lot Number 59222081923; DYND300050P, Lot Number 59220061157; DYND300050P, Lot Number 59220122559; DYND300050P, Lot Number 59220122896; DYND300050P, Lot Number 59221030489; DYND300050P, Lot Number 59221061255; DYND300050P, Lot Number 59221071370; DYND300050P, Lot Number 59221050956; DYND300050P, Lot Number 59221050960; DYND300050P, Lot Number 59221112515; DYND300050P, Lot Number 59221112403; DYND300050P, Lot Number 59221122696; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222051032; DYND300050P, Lot Number 59222061222; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222071690; DYND300050P, Lot Number 59222081778; DYND300050P, Lot Number 59222081923; DYNDJ1061A , Lot Number 21IBM637 ; DYNDJ1061A , Lot Number 21KBR259 ; DYNDJ1061A , Lot Number 19BBL149 ; DYNDJ1061A , Lot Number 22HBA163 ; DYNDJ1061A , Lot Number 22LBS593 ; DYNDJ1061A , Lot Number 23BBR453 ; DYNDJ1061A , Lot Number 20ABI199 ; DYNDJ1061A , Lot Number 20ABQ477 ; DYNDJ1061A , Lot Number 20BBV927 ; DYNDJ1061A , Lot Number 20CBZ583 ; DYNDJ1061A , Lot Number 23HBA926 ; DYNDJ1061A , Lot Number 23IBU987 ; DYNDJ1061A , Lot Number 23KBF024 ; DYNDJ1061A , Lot Number 23KBI637 ; DYNDJ1061A , Lot Number 20IBH461 ; DYNDJ1061A , Lot Number 20IBH534 ; DYNDJ1061A , Lot Number 20JBU615 ; DYNJ45495F , Lot Number 21DME648

Distribution pattern

Worldwide distribution.

device · product 3 of 81

Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number DYNDA1598C; 6) INTUBATION KIT , Pack Number DYNDA1598CH ; 7) ANESTHESIA KIT , Pack Number DYNDA2958; 8) ANESTHESIA PREP CUSTOM TRAY, Pack Number DYNDH1758; 9) ADULT LUMBAR PUNCTURE TRAY , Pack Number DYNDH1889; 10) PEDIATRIC CARDIAC PACK-LF, Pack Number DYNJ0537013Y; 11) PEDIATRIC MINOR PK, Pack Number DYNJ49035B; 12) WMC PEDIATRIC ADD ON PACK-LF, Pack Number DYNJ50644; 13) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283B; 14) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283C; 15) AIRWAY PACK , Pack Number DYNJ60239B; 16) ANESTHESIA PAIN PK LEAGUE, Pack Number DYNJ67925; 17) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603I ; 18) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603J ; 19) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503A ; 20) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503B ; 21) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503C ; 22) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503D ; 23) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503F ; 24) #######, Pack Number DYNJ905503F ; 25) MZ MDL AIRWAY, Pack Number DYNJ910129; 26) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA10379 ; 27) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA6572; 28) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 29) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 30) REGIONAL ANESTHESIA PREP TRAY , Pack Number DYNJRA0376A ; 31) ANESTHESIA KIT , Pack Number DYNJRA0424A ; 32) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767; 33) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767A ; 34) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767B ; 35) ANESTHESIA SUPPORT TRAY , Pack Number DYNJRA0779A ; 36) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0887A ; 37) ANESTHESIA TRAY, Pack Number DYNJRA0909; 38) SPINAL ANESTHESIA TRAY/WHITE, Pack Number DYNJRA0955A ; 39) #####, Pack Number DYNJRA0955A ; 40) ANESTHESIA SUPPORT TRAY/B, Pack Number DYNJRA0968; 41) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119; 42) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119A ; 43) ANESTHESIA TRAY, Pack Number DYNJRA1355; 44) ANESTHESIA TRAY, Pack Number DYNJRA1355A ; 45) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1577A ; 46) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659; 47) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659A ; 48) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1757; 49) ANESTHESIA PREP KIT, Pack Number DYNJRA1899; 50) ANESTHESIA TRAY, Pack Number DYNJRA1934; 51) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA2087; 52) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA2151; 53) PRE OP ANES KIT, Pack Number DYNJRA2228; 54) PRE OP ANES KIT, Pack Number DYNJRA2228H; 55) CUSTOM ANESTHESIA KIT-LF, Pack Number GSP478I; 56) REGIONAL TRAY, Pack Number PAIN0385B; 57) EPIDURAL ANESTHESIA KIT , Pack Number PAIN1982 ; 58) CIRC PACK-LF, Pack Number PHS41720I; 59) CIRC PACK-LF, Pack Number PHS41720J; 60) ANES CIRC 90 EXP, Pack Number VM96DLEX2L

Z-2983-2024
Recall number
Z-2983-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

35772, Lot Number 19GBK969 ; 81842, Lot Number 20JBS956 ; DYKE1796 , Lot Number 21GBR139 ; DYKE1796 , Lot Number 22HBX360 ; DYKE1796 , Lot Number 22JBR572 ; DYKSCRIPPSIN4, Lot Number 19DAA326 ; DYKSCRIPPSIN4, Lot Number 19EAA345 ; DYKSCRIPPSIN4, Lot Number 19HAB271 ; DYKSCRIPPSIN4, Lot Number 19LAA719 ; DYKSCRIPPSIN4, Lot Number 20AAA102 ; DYKSCRIPPSIN4, Lot Number 20BAA611 ; DYKSCRIPPSIN4, Lot Number 20DAA064 ; DYNDA1598C , Lot Number 23KMF159 ; DYNDA1598C , Lot Number 24AMG428 ; DYNDA1598CH, Lot Number 23KMF159 ; DYNDA1598CH, Lot Number 24AMG428 ; DYNDA2958, Lot Number 22KBH750 ; DYNDH1758, Lot Number 22HBX410 ; DYNDH1758, Lot Number 22JBU749 ; DYNDH1758, Lot Number 22LBK163 ; DYNDH1889, Lot Number 23HBZ539 ; DYNDH1889, Lot Number 23KBG134 ; DYNJ0537013Y , Lot Number 21LMD783 ; DYNJ49035B , Lot Number 19BDA167 ; DYNJ49035B , Lot Number 19CDC764 ; DYNJ49035B , Lot Number 19EDD455 ; DYNJ49035B , Lot Number 19GDC256 ; DYNJ49035B , Lot Number 19IDC024 ; DYNJ49035B , Lot Number 20ADA825 ; DYNJ49035B , Lot Number 20BDC864 ; DYNJ49035B , Lot Number 20DDA660 ; DYNJ49035B , Lot Number 20GDB084 ; DYNJ49035B , Lot Number 20IDB475 ; DYNJ49035B , Lot Number 20LDA638 ; DYNJ50644, Lot Number 21KBE704 ; DYNJ50644, Lot Number 22OBH075 ; DYNJ50644, Lot Number 22HBD748 ; DYNJ50644, Lot Number 19HBZ833 ; DYNJ50644, Lot Number 19JBI231 ; DYNJ50644, Lot Number 19VBB145 ; DYNJ50644, Lot Number 20BBB196 ; DYNJ50644, Lot Number 23JBW861 ; DYNJ52283B , Lot Number 19ABX422 ; DYNJ52283B , Lot Number 19BBT964 ; DYNJ52283C , Lot Number 21IBF288 ; DYNJ52283C , Lot Number 21JBX031 ; DYNJ52283C , Lot Number 21LBB738 ; DYNJ52283C , Lot Number 22ABA824 ; DYNJ52283C , Lot Number 22OBI904 ; DYNJ52283C , Lot Number 19DBO272 ; DYNJ52283C , Lot Number 19DBU670 ; DYNJ52283C , Lot Number 19FBM983 ; DYNJ52283C , Lot Number 22HBE294 ; DYNJ52283C , Lot Number 19GBL569 ; DYNJ52283C , Lot Number 19GBW600 ; DYNJ52283C , Lot Number 19SBC949 ; DYNJ52283C , Lot Number 22JBN210 ; DYNJ52283C , Lot Number 19JBT368 ; DYNJ52283C , Lot Number 19JBV109 ; DYNJ52283C , Lot Number 19VBH492 ; DYNJ52283C , Lot Number 19KBJ678 ; DYNJ52283C , Lot Number 19KBN283 ; DYNJ52283C , Lot Number 23BBU977 ; DYNJ52283C , Lot Number 19LBK922 ; DYNJ52283C , Lot Number 19LBS004 ; DYNJ52283C , Lot Number 20ABM461 ; DYNJ52283C , Lot Number 20ABP865 ; DYNJ52283C , Lot Number 23EBL084 ; DYNJ52283C , Lot Number 20BBJ414 ; DYNJ52283C , Lot Number 20BBS280 ; DYNJ52283C , Lot Number 23FBP678 ; DYNJ52283C , Lot Number 23HBK734 ; DYNJ52283C , Lot Number 20HBH238 ; DYNJ52283C , Lot Number 20JBJ550 ; DYNJ52283C , Lot Number 20JBN445 ; DYNJ52283C , Lot Number 20KBA832 ; DYNJ52283C , Lot Number 20KBP071 ; DYNJ52283C , Lot Number 21ABN133 ; DYNJ60239B , Lot Number 23LDA663 ; DYNJ67925, Lot Number 21GBR614 ; DYNJ67925, Lot Number 21JBL671 ; DYNJ67925, Lot Number 21LBO778 ; DYNJ67925, Lot Number 21LBO779 ; DYNJ67925, Lot Number 21LBO780 ; DYNJ67925, Lot Number 21LBO781 ; DYNJ67925, Lot Number 22ABA751 ; DYNJ67925, Lot Number 22ABQ043 ; DYNJ67925, Lot Number 22BBL497 ; DYNJ67925, Lot Number 22GBR405 ; DYNJ67925, Lot Number 22HBF644 ; DYNJ67925, Lot Number 22IBQ399 ; DYNJ67925, Lot Number 22KBU314 ; DYNJ67925, Lot Number 23ABO072 ; DYNJ67925, Lot Number 23ABT720 ; DYNJ67925, Lot Number 23CBF754 ; DYNJ67925, Lot Number 23DBP494 ; DYNJ67925, Lot Number 23FBJ744 ; DYNJ67925, Lot Number 23GBQ403 ; DYNJ67925, Lot Number 23HBE106 ; DYNJ67925, Lot Number 21ABA903 ; DYNJ67925, Lot Number 21ABW854 ; DYNJ67925, Lot Number 21DBP686 ; DYNJ67925, Lot Number 21EBH092 ; DYNJ900603I, Lot Number 20DDB314 ; DYNJ900603I, Lot Number 20FDB651 ; DYNJ900603I, Lot Number 20GDA926 ; DYNJ900603I, Lot Number 20HDA245 ; DYNJ900603I, Lot Number 20JDB313 ; DYNJ900603I, Lot Number 20JDB761 ; DYNJ900603I, Lot Number 20LDB998 ; DYNJ900603I, Lot Number 21ADB434 ; DYNJ900603I, Lot Number 21BDA664 ; DYNJ900603J, Lot Number 21HDC941 ; DYNJ900603J, Lot Number 21IDB264 ; DYNJ905503A, Lot Number 19CBB091 ; DYNJ905503A, Lot Number 19DBG305 ; DYNJ905503A, Lot Number 19PBB724 ; DYNJ905503A, Lot Number 19QBB679 ; DYNJ905503B, Lot Number 19FBZ308 ; DYNJ905503B, Lot Number 19HBV183 ; DYNJ905503B, Lot Number 19IBY178 ; DYNJ905503B, Lot Number 19LBP039 ; DYNJ905503C, Lot Number 20MBA222 ; DYNJ905503C, Lot Number 20CBF593 ; DYNJ905503C, Lot Number 20EBK549 ; DYNJ905503C, Lot Number 20EBO464 ; DYNJ905503C, Lot Number 20HBU177 ; DYNJ905503D, Lot Number 21FBN751 ; DYNJ905503D, Lot Number 20LBP237 ; DYNJ905503D, Lot Number 21DBG611 ; DYNJ905503D, Lot Number 21EBI605 ; DYNJ905503F, Lot Number 21HBL060 ; DYNJ905503F, Lot Number 21IBW859 ; DYNJ905503F, Lot Number 22DBC340 ; DYNJ905503F, Lot Number 22DBS437 ; DYNJ905503F, Lot Number 22FBR267 ; DYNJ905503F, Lot Number 22GBR286 ; DYNJ905503F, Lot Number 22HBS560 ; DYNJ905503F, Lot Number 22IBA577 ; DYNJ905503F, Lot Number 22JBI883 ; DYNJ905503F, Lot Number 22KBD587 ; DYNJ905503F, Lot Number 22LBF425 ; DYNJ905503F, Lot Number 23BBN903 ; DYNJ905503F, Lot Number 23CBL450 ; DYNJ905503F, Lot Number 23CBW776 ; DYNJ905503F, Lot Number 23FBC209 ; DYNJ905503F, Lot Number 23IBU343 ; DYNJ905503F, Lot Number 23JBP494 ; DYNJ905503F, Lot Number 23KBH749 ; DYNJ905503F, Lot Number 23KBQ236 ; DYNJ905503F, Lot Number 23LBR048 ; DYNJ905503F, Lot Number 24BBH974 ; DYNJ910129 , Lot Number 24AMF749 ; DYNJAA10379, Lot Number 19HBV537 ; DYNJAA6572 , Lot Number 20FBL919 ; DYNJAASAMPLE, Lot Number 21IBA814; DYNJAASAMPLE, Lot Number 21IBA815; DYNJAASAMPLE, Lot Number 21HBE107; DYNJAASAMPLE, Lot Number 21FBU433; DYNJAASAMPLE, Lot Number 21EBM583; DYNJAASAMPLE , Lot Number 19HBP877 ; DYNJAASAMPLE , Lot Number 19KBF202 ; DYNJRA0376A, Lot Number 21JBA836 ; DYNJRA0376A, Lot Number 21KBI074 ; DYNJRA0376A, Lot Number 21KBP359 ; DYNJRA0376A, Lot Number 21KBU250 ; DYNJRA0376A, Lot Number 22ABU499 ; DYNJRA0376A, Lot Number 19ABT679 ; DYNJRA0376A, Lot Number 19BBH464 ; DYNJRA0376A, Lot Number 19CBM742 ; DYNJRA0376A, Lot Number 19DBV170 ; DYNJRA0376A, Lot Number 19EBC310 ; DYNJRA0376A, Lot Number 19EBZ313 ; DYNJRA0376A, Lot Number 19FBP671 ; DYNJRA0376A, Lot Number 22JBU142 ; DYNJRA0376A, Lot Number 19IBN472 ; DYNJRA0376A, Lot Number 19JBN388 ; DYNJRA0376A, Lot Number 23ABN343 ; DYNJRA0376A, Lot Number 19WBB195 ; DYNJRA0376A, Lot Number 23DBN153 ; DYNJRA0376A, Lot Number 20ABP822 ; DYNJRA0376A, Lot Number 20BBG986 ; DYNJRA0376A, Lot Number 23FBJ727 ; DYNJRA0376A, Lot Number 20FBS238 ; DYNJRA0376A, Lot Number 23JBT431 ; DYNJRA0376A, Lot Number 20JBB325 ; DYNJRA0376A, Lot Number 20JBS327 ; DYNJRA0376A, Lot Number 21CBC005 ; DYNJRA0376A, Lot Number 21FBA847 ; DYNJRA0376A, Lot Number 21FBF515 ; DYNJRA0424A, Lot Number 19BLA192 ; DYNJRA0424A, Lot Number 19ELA369 ; DYNJRA0424A, Lot Number 19ILA097 ; DYNJRA0424A, Lot Number 19ILA581 ; DYNJRA0424A, Lot Number 20BLA165 ; DYNJRA0424A, Lot Number 20DLA320 ; DYNJRA0424A, Lot Number 20ILA236 ; DYNJRA0424A, Lot Number 20ILA689 ; DYNJRA0424A, Lot Number 20JLA266 ; DYNJRA0767 , Lot Number 19ABB420 ; DYNJRA0767 , Lot Number 19ABB495 ; DYNJRA0767 , Lot Number 19BBB590 ; DYNJRA0767 , Lot Number 19EBV290 ; DYNJRA0767A, Lot Number 19GLA471 ; DYNJRA0767A, Lot Number 19JLA131 ; DYNJRA0767A, Lot Number 19KLA574 ; DYNJRA0767A, Lot Number 20ALA762 ; DYNJRA0767B, Lot Number 20BLA575 ; DYNJRA0767B, Lot Number 20DLA137 ; DYNJRA0767B, Lot Number 20GLA730 ; DYNJRA0767B, Lot Number 20ILA116 ; DYNJRA0767B, Lot Number 20KLA503 ; DYNJRA0767B, Lot Number 20LLA193 ; DYNJRA0767B, Lot Number 21ALA504 ; DYNJRA0767B, Lot Number 21DLA280 ; DYNJRA0767B, Lot Number 21ELA804 ; DYNJRA0767B, Lot Number 21GLA351 ; DYNJRA0779A, Lot Number 19BBE138 ; DYNJRA0887A, Lot Number 21HBJ813 ; DYNJRA0887A, Lot Number 21KBF202 ; DYNJRA0887A, Lot Number 22ABL039 ; DYNJRA0887A, Lot Number 19ABB764 ; DYNJRA0887A, Lot Number 22BBO561 ; DYNJRA0887A, Lot Number 22DBL385 ; DYNJRA0887A, Lot Number 22DBL387 ; DYNJRA0887A, Lot Number 19DBQ652 ; DYNJRA0887A, Lot Number 22EBN188 ; DYNJRA0887A, Lot Number 19EBM156 ; DYNJRA0887A, Lot Number 22FBN499 ; DYNJRA0887A, Lot Number 19FBG819 ; DYNJRA0887A, Lot Number 19GBN973 ; DYNJRA0887A, Lot Number 20ABG794 ; DYNJRA0887A, Lot Number 23EBA855 ; DYNJRA0887A, Lot Number 20CBA118 ; DYNJRA0887A, Lot Number 20CBT347 ; DYNJRA0887A, Lot Number 20CBZ291 ; DYNJRA0887A, Lot Number 23HBX546 ; DYNJRA0887A, Lot Number 20EBP521 ; DYNJRA0887A, Lot Number 23IBM658 ; DYNJRA0887A, Lot Number 20GBA834 ; DYNJRA0887A, Lot Number 23JBY667 ; DYNJRA0887A, Lot Number 23LBA050 ; DYNJRA0887A, Lot Number 20KBS435 ; DYNJRA0887A, Lot Number 20WBA633 ; DYNJRA0887A, Lot Number 20LBU607 ; DYNJRA0909 , Lot Number 21IBM432 ; DYNJRA0909 , Lot Number 21JBB919 ; DYNJRA0909 , Lot Number 21JBJ840 ; DYNJRA0909 , Lot Number 21LBI511 ; DYNJRA0909 , Lot Number 22BBK053 ; DYNJRA0909 , Lot Number 19ABK394 ; DYNJRA0909 , Lot Number 22CBV876 ; DYNJRA0909 , Lot Number 19DBH758 ; DYNJRA0909 , Lot Number 22EBB982 ; DYNJRA0909 , Lot Number 19EBX778 ; DYNJRA0909 , Lot Number 19SBA717 ; DYNJRA0909 , Lot Number 19IBH329 ; DYNJRA0909 , Lot Number 22KBK484 ; DYNJRA0909 , Lot Number 22LBH510 ; DYNJRA0909 , Lot Number 19KBD605 ; DYNJRA0909 , Lot Number 23BBS655 ; DYNJRA0909 , Lot Number 19KBX403 ; DYNJRA0909 , Lot Number 23DBC885 ; DYNJRA0909 , Lot Number 20BBQ111 ; DYNJRA0909 , Lot Number 20BBR726 ; DYNJRA0909 , Lot Number 23FBK613 ; DYNJRA0909 , Lot Number 23GBT449 ; DYNJRA0909 , Lot Number 23IBL594 ; DYNJRA0909 , Lot Number 20FBN090 ; DYNJRA0909 , Lot Number 23KBC242 ; DYNJRA0909 , Lot Number 20HBN921 ; DYNJRA0909 , Lot Number 23LBU798 ; DYNJRA0909 , Lot Number 20JBS343 ; DYNJRA0909 , Lot Number 20LBP468 ; DYNJRA0909 , Lot Number 21OBA552 ; DYNJRA0909 , Lot Number 21FBD258 ; DYNJRA0955A, Lot Number 19ADB360 ; DYNJRA0955A, Lot Number 19EDB618 ; DYNJRA0955A, Lot Number 19HDA472 ; DYNJRA0955A, Lot Number 20ADC459 ; DYNJRA0955A, Lot Number 20CDB147 ; DYNJRA0955A, Lot Number 20FDC321 ; DYNJRA0955A, Lot Number 20HDC485 ; DYNJRA0955A, Lot Number 20JDA615 ; DYNJRA0955A, Lot Number 20LDA004 ; DYNJRA0955A, Lot Number 20LDB451 ; DYNJRA0955A, Lot Number 21ADA927 ; DYNJRA0955A, Lot Number 21EDB811 ; DYNJRA0955A, Lot Number 21IDB370 ; DYNJRA0955A, Lot Number 21JDA420 ; DYNJRA0955A, Lot Number 21KDB440 ; DYNJRA0955A, Lot Number 21LDA933 ; DYNJRA0955A, Lot Number 22BDB266 ; DYNJRA0955A, Lot Number 22EDB897 ; DYNJRA0955A, Lot Number 22JDA402 ; DYNJRA0955A, Lot Number 22LDB425 ; DYNJRA0955A, Lot Number 23BDA481 ; DYNJRA0955A, Lot Number 23EDA343 ; DYNJRA0955A, Lot Number 23IDB489 ; DYNJRA0955A, Lot Number 23LDA640 ; DYNJRA0955A, Lot Number 24ADC151 ; DYNJRA0955A, Lot Number 24CDA833 ; DYNJRA0968 , Lot Number 21HBF288 ; DYNJRA0968 , Lot Number 21JBT830 ; DYNJRA0968 , Lot Number 21LBY093 ; DYNJRA0968 , Lot Number 19BBE830 ; DYNJRA0968 , Lot Number 22OBI659 ; DYNJRA0968 , Lot Number 19DBR761 ; DYNJRA0968 , Lot Number 22EBT662 ; DYNJRA0968 , Lot Number 19EBR863 ; DYNJRA0968 , Lot Number 19FBV435 ; DYNJRA0968 , Lot Number 22JBL305 ; DYNJRA0968 , Lot Number 19IBU668 ; DYNJRA0968 , Lot Number 19KBO051 ; DYNJRA0968 , Lot Number 20BBQ119 ; DYNJRA0968 , Lot Number 20EBA140 ; DYNJRA0968 , Lot Number 20HBV152 ; DYNJRA1119 , Lot Number 19ABB888 ; DYNJRA1119 , Lot Number 19ABF794 ; DYNJRA1119 , Lot Number 19DBS320 ; DYNJRA1119 , Lot Number 19FBU183 ; DYNJRA1119 , Lot Number 19JBJ900 ; DYNJRA1119 , Lot Number 19LBI573 ; DYNJRA1119 , Lot Number 20CBO496 ; DYNJRA1119 , Lot Number 20EBA135 ; DYNJRA1119 , Lot Number 20FBC818 ; DYNJRA1119 , Lot Number 20KBC430 ; DYNJRA1119 , Lot Number 20KBS507 ; DYNJRA1119 , Lot Number 20WBA649 ; DYNJRA1119 , Lot Number 20XBA718 ; DYNJRA1119A, Lot Number 21LBM005 ; DYNJRA1119A, Lot Number 22OBE977 ; DYNJRA1119A, Lot Number 22OBG228 ; DYNJRA1119A, Lot Number 22OBH490 ; DYNJRA1119A, Lot Number 22DBL388 ; DYNJRA1119A, Lot Number 22DBL389 ; DYNJRA1119A, Lot Number 22DBL390 ; DYNJRA1119A, Lot Number 22HBM810 ; DYNJRA1119A, Lot Number 22IBT110 ; DYNJRA1355 , Lot Number 19DDB243 ; DYNJRA1355 , Lot Number 20EDB062 ; DYNJRA1355 , Lot Number 20KDA418 ; DYNJRA1355 , Lot Number 21HDA638 ; DYNJRA1355 , Lot Number 21KDC271 ; DYNJRA1355 , Lot Number 22BDB953 ; DYNJRA1355 , Lot Number 22CDA294 ; DYNJRA1355A, Lot Number 23EBS294 ; DYNJRA1355A, Lot Number 23FBB136 ; DYNJRA1355A, Lot Number 23LBU793 ; DYNJRA1577A, Lot Number 20BLA161 ; DYNJRA1577A, Lot Number 20GLA679 ; DYNJRA1577A, Lot Number 20HLA024 ; DYNJRA1577A, Lot Number 21DLA789 ; DYNJRA1577A, Lot Number 21HLA237 ; DYNJRA1577A, Lot Number 21JLA880 ; DYNJRA1577A, Lot Number 22ALA178 ; DYNJRA1577A, Lot Number 22FLB148 ; DYNJRA1577A, Lot Number 22JLA138 ; DYNJRA1577A, Lot Number 22KLA017 ; DYNJRA1659 , Lot Number 20GBL316 ; DYNJRA1659A, Lot Number 21HBL723 ; DYNJRA1659A, Lot Number 21KBD763 ; DYNJRA1659A, Lot Number 22ABH121 ; DYNJRA1659A, Lot Number 22BBH682 ; DYNJRA1659A, Lot Number 22EBO710 ; DYNJRA1659A, Lot Number 20JBK938 ; DYNJRA1659A, Lot Number 20KBS464 ; DYNJRA1659A, Lot Number 20KBX281 ; DYNJRA1659A, Lot Number 20XBB194 ; DYNJRA1659A, Lot Number 21DBO798 ; DYNJRA1659A, Lot Number 21DBU473 ; DYNJRA1659A, Lot Number 22GMG057 ; DYNJRA1659A, Lot Number 22JMG120 ; DYNJRA1757 , Lot Number 21GBH846 ; DYNJRA1757 , Lot Number 21HBI684 ; DYNJRA1757 , Lot Number 21HBL719 ; DYNJRA1757 , Lot Number 21JBB912 ; DYNJRA1757 , Lot Number 21JBX538 ; DYNJRA1757 , Lot Number 21LBP546 ; DYNJRA1757 , Lot Number 22ABN356 ; DYNJRA1757 , Lot Number 22ABU537 ; DYNJRA1757 , Lot Number 22EBI319 ; DYNJRA1757 , Lot Number 22GBD823 ; DYNJRA1757 , Lot Number 22HBL721 ; DYNJRA1757 , Lot Number 22LBC462 ; DYNJRA1757 , Lot Number 23ABF387 ; DYNJRA1757 , Lot Number 23BBC744 ; DYNJRA1757 , Lot Number 23CBR306 ; DYNJRA1757 , Lot Number 23EBE047 ; DYNJRA1757 , Lot Number 23GBM489 ; DYNJRA1757 , Lot Number 23IBW129 ; DYNJRA1757 , Lot Number 23KBX075 ; DYNJRA1757 , Lot Number 21CBD668 ; DYNJRA1757 , Lot Number 21EBI263 ; DYNJRA1757 , Lot Number 21FBC480 ; DYNJRA1899 , Lot Number 22BBB022 ; DYNJRA1899 , Lot Number 22FBN862 ; DYNJRA1899 , Lot Number 23ABG680 ; DYNJRA1899 , Lot Number 23CBR650 ; DYNJRA1899 , Lot Number 23EBX287 ; DYNJRA1899 , Lot Number 23KBW986 ; DYNJRA1934 , Lot Number 22FBG297 ; DYNJRA1934 , Lot Number 22JBO101 ; DYNJRA1934 , Lot Number 23GBP086 ; DYNJRA1934 , Lot Number 23IBM814 ; DYNJRA1934 , Lot Number 23KBB573 ; DYNJRA1934 , Lot Number 23LBB359 ; DYNJRA2087 , Lot Number 23ABU062 ; DYNJRA2087 , Lot Number 23FBK599 ; DYNJRA2151 , Lot Number 23DBD158 ; DYNJRA2228, Lot Number 23IBH340; DYNJRA2228H, Lot Number 23IBH340; GSP478I, Lot Number 21GBH137 ; GSP478I, Lot Number 19DBC561 ; GSP478I, Lot Number 19EBJ393 ; GSP478I, Lot Number 19GBY924 ; GSP478I, Lot Number 19TBC432 ; GSP478I, Lot Number 19JBI604 ; GSP478I, Lot Number 19KBD438 ; GSP478I, Lot Number 20ABK386 ; GSP478I, Lot Number 20ABO197 ; GSP478I, Lot Number 20EBN095 ; GSP478I, Lot Number 20GBG243 ; GSP478I, Lot Number 20JBN525 ; GSP478I, Lot Number 20KBK235 ; GSP478I, Lot Number 20WBB596 ; GSP478I, Lot Number 21BBI524 ; GSP478I, Lot Number 21DBN817 ; PAIN0385B, Lot Number 19EDB505 ; PAIN1982 , Lot Number 23IBE536 ; PAIN1982 , Lot Number 23KBC691 ; PAIN1982 , Lot Number 23LBC334 ; PAIN1982 , Lot Number 23LBC459 ; PHS41720I, Lot Number 20JMC326 ; PHS41720I, Lot Number 20KMF038 ; PHS41720I, Lot Number 19KKB847 ; PHS41720I, Lot Number 19LKB657 ; PHS41720I, Lot Number 20EKB947 ; PHS41720I, Lot Number 20GKB697 ; PHS41720I, Lot Number 20IKB163 ; PHS41720J, Lot Number 21BMD711 ; PHS41720J, Lot Number 21CME416 ; PHS41720J, Lot Number 21GMB611 ; PHS41720J, Lot Number 21IMB848 ; PHS41720J, Lot Number 21LMA466 ; PHS41720J, Lot Number 22AMC812 ; PHS41720J, Lot Number 22CMH766 ; PHS41720J, Lot Number 22EMD326 ; PHS41720J, Lot Number 22HMB227 ; PHS41720J, Lot Number 22JMF258 ; PHS41720J, Lot Number 23AMB719 ; PHS41720J, Lot Number 23CMI096 ; PHS41720J, Lot Number 23EMD393 ; PHS41720J, Lot Number 23FMD285 ; PHS41720J, Lot Number 23GMI391 ; PHS41720J, Lot Number 23HMF798 ; PHS41720J, Lot Number 23JMH827 ; PHS41720J, Lot Number 24AMB622 ; VM96DLEX2L , Lot Number 22DBC917

Distribution pattern

Worldwide distribution.

device · product 4 of 81

Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B ; 6) ENT TRACHEOTOMY , Pack Number DYNJ55523C ; 7) DR NIELSON THORACOSCOPY , Pack Number DYNJ61471A ; 8) TRACH PACK, Pack Number DYNJ64583; 9) TRACHEOSTOMY, Pack Number DYNJ902123G; 10) TRACHEOSTOMY, Pack Number DYNJ902123I; 11) TRACHEOSTOMY, Pack Number DYNJ902123J; 12) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525 ; 13) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525H; 14) BEDSIDE TRACHEOTOMY , Pack Number DYNJ909743

Z-2984-2024
Recall number
Z-2984-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDA1894, Lot Number 21HBD322 ; DYNDA1894, Lot Number 21HBF874 ; DYNDA1894, Lot Number 21IBL847 ; DYNDA1894, Lot Number 21JBM308 ; DYNDA1894, Lot Number 21KBS529 ; DYNDA1894, Lot Number 19ABT326 ; DYNDA1894, Lot Number 22CBG860 ; DYNDA1894, Lot Number 19BBD317 ; DYNDA1894, Lot Number 19CBV464 ; DYNDA1894, Lot Number 22JBO787 ; DYNDA1894, Lot Number 23CBL463 ; DYNDA1894, Lot Number 23JBP440 ; DYNDA1894, Lot Number 23KBX335 ; DYNDA1894, Lot Number 20LBS038 ; DYNDA1894, Lot Number 21BBO392 ; DYNDA1894, Lot Number 24ABL991 ; DYNJ46518G , Lot Number 21KBO731 ; DYNJ46518G , Lot Number 21LBN631 ; DYNJ46518G , Lot Number 21LBN633 ; DYNJ50007A , Lot Number 19EBV606 ; DYNJ50007B , Lot Number 19VBF523 ; DYNJ50007B , Lot Number 19VBG533 ; DYNJ55523C , Lot Number 22BBB625 ; DYNJ55523C , Lot Number 22EBN464 ; DYNJ55523C , Lot Number 22FBX756 ; DYNJ55523C , Lot Number 23ABB987 ; DYNJ55523C , Lot Number 23BBR466 ; DYNJ55523C , Lot Number 23CBP129 ; DYNJ55523C , Lot Number 23EBW287 ; DYNJ55523C , Lot Number 23HBO179 ; DYNJ55523C , Lot Number 23JBN656 ; DYNJ61471A , Lot Number 21HBE324 ; DYNJ61471A , Lot Number 21LBO974 ; DYNJ61471A , Lot Number 22BBY429 ; DYNJ61471A , Lot Number 22DBQ350 ; DYNJ61471A , Lot Number 22LBJ146 ; DYNJ61471A , Lot Number 23CBP132 ; DYNJ61471A , Lot Number 23IBE187 ; DYNJ61471A , Lot Number 23KBB186 ; DYNJ64583, Lot Number 21IBC649 ; DYNJ64583, Lot Number 21IBJ828 ; DYNJ64583, Lot Number 21IBS979 ; DYNJ64583, Lot Number 22GBO053 ; DYNJ64583, Lot Number 22LBB121 ; DYNJ64583, Lot Number 19KBI997 ; DYNJ64583, Lot Number 23FBA258 ; DYNJ64583, Lot Number 23KBV611 ; DYNJ64583, Lot Number 24ABM408 ; DYNJ909525 , Lot Number 23EBJ496 ; DYNJ909525 , Lot Number 23HBH829 ; DYNJ909525 , Lot Number 23IBD159 ; DYNJ909525 , Lot Number 23LBF615 ; DYNJ902123G, Lot Number 21FDB495 ; DYNJ902123G, Lot Number 21HDA217 ; DYNJ902123G, Lot Number 21KDA143 ; DYNJ902123G, Lot Number 21LDA525 ; DYNJ902123G, Lot Number 22CDB069 ; DYNJ902123G, Lot Number 22GDB802 ; DYNJ902123G, Lot Number 22HDA871 ; DYNJ902123G, Lot Number 23ADB623 ; DYNJ902123G, Lot Number 23BDA748 ; DYNJ902123I, Lot Number 23HDB751 ; DYNJ902123I, Lot Number 23IDB087 ; DYNJ902123J, Lot Number 23JDB498 ; DYNJ902123J, Lot Number 24BDB737 ; DYNJ45495G , Lot Number 21HMG197 ; DYNJ45495G , Lot Number 21IMB564 ; DYNJ45495G , Lot Number 21KMB040 ; DYNJ45495G , Lot Number 22DMC103 ; DYNJ45495G , Lot Number 22FMC965 ; DYNJ45495G , Lot Number 22IMI120 ; DYNJ45495G , Lot Number 23AME356 ; DYNJ45495G , Lot Number 23BMA551 ; DYNJ45495G , Lot Number 23DMC990 ; DYNJ45495G , Lot Number 23IMF939 ; DYNJ45495G , Lot Number 23KME498 ; DYNJ45495G , Lot Number 23LMB979 ; DYNJ45495G , Lot Number 24AMA042 ; DYNJ46518G , Lot Number 22EMG387 ; DYNJ46518G , Lot Number 22HMD287 ; DYNJ46518G , Lot Number 22JMA904 ; DYNJ46518G , Lot Number 22JMB321 ; DYNJ46518G , Lot Number 23BMC141 ; DYNJ46518G , Lot Number 23CMD470 ; DYNJ46518G , Lot Number 23DME173 ; DYNJ46518G , Lot Number 23FMA265 ; DYNJ909743 , Lot Number 23KLA140 ; DYNJ909743 , Lot Number 23KLA204 ; DYNJ909525H, Lot Number 23EBJ496 ; DYNJ909525H, Lot Number 23HBH829 ; DYNJ909525H, Lot Number 23IBD159 ; DYNJ909525H, Lot Number 23LBF615

Distribution pattern

Worldwide distribution.

device · product 5 of 81

Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK

Z-2985-2024
Recall number
Z-2985-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ59573A , Lot Number 23IBP764 ; DYNJ59573A , Lot Number 23JBM050 ; DYNJ59573A , Lot Number 23KBM610 ; DYNJ59573A , Lot Number 24ABC779 ; DYNJ39451D , Lot Number 22BDB647 ; DYNJ39451D , Lot Number 22CDA099 ; DYNJ39451D , Lot Number 22LDA195 ; DYNJ39451D , Lot Number 23DDB501 ; DYNJ39451D , Lot Number 23DDB666 ; DYNJ39451D , Lot Number 23EDA821 ; DYNJ80281A , Lot Number 23ADA194 ; DYNJ80281A , Lot Number 23DDA881 ; DYNJ80281A , Lot Number 23HDA513 ; DYNJ80281A , Lot Number 23JDC172 ; DYNJ80281A , Lot Number 23LDB860 ; DYNJ80281A , Lot Number 24ADC258 ; DYNJ80281A , Lot Number 24CDA973

Distribution pattern

Worldwide distribution.

device · product 6 of 81

Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMHS, Pack Number DYNJ58876A

Z-2986-2024
Recall number
Z-2986-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDM1076A . Lot Number 19CBP748 ; DYNDM1076A . Lot Number 19DBH317 ; DYNDM1076A . Lot Number 19FBT944 ; DYNJ45158A . Lot Number 21KBK059 ; DYNJ45158A . Lot Number 21LBB289 ; DYNJ45158A . Lot Number 19ABZ159 ; DYNJ45158A . Lot Number 22DBS953 ; DYNJ45158A . Lot Number 22GBC899 ; DYNJ45158A . Lot Number 22GBE801 ; DYNJ45158A . Lot Number 19FBG969 ; DYNJ45158A . Lot Number 19FBM779 ; DYNJ45158A . Lot Number 19GBS210 ; DYNJ45158A . Lot Number 19HBS882 ; DYNJ45158A . Lot Number 19IBN282 ; DYNJ45158A . Lot Number 19JBB002 ; DYNJ45158A . Lot Number 23ABR333 ; DYNJ45158A . Lot Number 23CBK931 ; DYNJ45158A . Lot Number 23HBJ279 ; DYNJ45158A . Lot Number 23IBF733 ; DYNJ45158A . Lot Number 20HBR669 ; DYNJ45158A . Lot Number 20HBX586 ; DYNJ45158A . Lot Number 20LBZ104 ; DYNJ45158A . Lot Number 21EBP316 ; DYNJ51939. Lot Number 22CBA086 ; DYNJ51939. Lot Number 19ABY439 ; DYNJ51939. Lot Number 22OBI663 ; DYNJ51939. Lot Number 19HBH583 ; DYNJ51939. Lot Number 19IBU567 ; DYNJ51939. Lot Number 19JBW741 ; DYNJ51939. Lot Number 19JBX646 ; DYNJ51939. Lot Number 20FBT320 ; DYNJ51939. Lot Number 20LBF765 ; DYNJ51939. Lot Number 20LBK574 ; DYNJ56573. Lot Number 19ABN855 ; DYNJ56573. Lot Number 19CBF516 ; DYNJ56573. Lot Number 19EBQ417 ; DYNJ56573. Lot Number 19HBP237 ; DYNJ56573. Lot Number 19UBC593 ; DYNJ56573. Lot Number 19VBA937 ; DYNJ56573. Lot Number 19KBB135 ; DYNJ58876A . Lot Number 20HBW903 ; DYNJ58876A . Lot Number 20IBJ399 ; DYNJ58876A . Lot Number 20IBM299

Distribution pattern

Worldwide distribution.

device · product 7 of 81

Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL PACK-LF, Pack Number DYNJ0957053DH; 6) SINGLE SHOT TRAY, Pack Number DYNJ32736; 7) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352A ; 8) SINGLE SHOT EPIDURAL-LF , Pack Number DYNJ36046A ; 9) PHOENIXVILLE EPIDURAL TRAY, Pack Number DYNJ40991A ; 10) UNIVERSAL SCOPE PACK, Pack Number DYNJ45052A ; 11) SPINAL PACK , Pack Number DYNJ48916B ; 12) PUH SPINAL BLOCK TRAY , Pack Number DYNJ49205B ; 13) EPIDURAL PACK , Pack Number DYNJ50772A ; 14) TRANSFORAMINAL PACK , Pack Number DYNJC3420D ; 15) EPIDURAL PREP TRAY-LF , Pack Number DYNJRA0135B; 16) SUPPORT TRAY-LF, Pack Number DYNJRA0198; 17) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0245 ; 18) EPIDURAL TRAY , Pack Number DYNJRA0260 ; 19) SPINAL EPIDURAL (TUOHY) PF, Pack Number DYNJRA0270B; 20) EPIDURAL TRAY-LF, Pack Number DYNJRA0275A; 21) SPINAL BLOCK TRAY- LF , Pack Number DYNJRA0413B; 22) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number DYNJRA0506A; 23) EPIDURAL TRAY , Pack Number DYNJRA0508 ; 24) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0555 ; 25) COMBINED SPINAL/EPIDURAL PACK , Pack Number DYNJRA0635 ; 26) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA0766 ; 27) TRANSFORAMINAL 22X5PF , Pack Number DYNJRA0777F; 28) TRANSFORMINAL TRAY, Pack Number DYNJRA0822A; 29) SPINAL TRAY, Pack Number DYNJRA0836A; 30) SPINAL TRAY , Pack Number DYNJRA0978A; 31) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0988 ; 32) TRAY, SPINAL, WHIT 24GX4, Pack Number DYNJRA1034 ; 33) TRANSFORAMINAL TRAY , Pack Number DYNJRA1730A; 34) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028 ; 35) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028H; 36) TRAY, SPINAL PENCIL POINT 25G , Pack Number DYNJRA9030 ; 37) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036 ; 38) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036H; 39) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA9037 ; 40) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0012 ; 41) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0024D; 42) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0055A; 43) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0058D; 44) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0078C; 45) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0082D; 46) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0111C; 47) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0133 ; 48) COMPLETE SINGLE SHOT TRAY , Pack Number PAIN0136A; 49) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0146C; 50) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0157G; 51) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0171C; 52) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0191I; 53) NORTON SINGLE SHOT EPIDURAL , Pack Number PAIN0215A; 54) EPIDURAL TRAY , Pack Number PAIN0225 ; 55) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0242B; 56) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0250A; 57) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0256B; 58) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0261A; 59) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0262A; 60) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0265C; 61) EPI TRAY, SINGLE , 20G-LF , Pack Number PAIN0274A; 62) EPI TRAY CONTI 17G TUOHY, Pack Number PAIN0275 ; 63) EPIDURAL TRAY-LF, Pack Number PAIN0279C; 64) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0280C; 65) SINGLE DOSE EPI-LF, Pack Number PAIN0300B; 66) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0317A; 67) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0334A; 68) EPIDURAL TRAY-LF, Pack Number PAIN0349B; 69) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0357B; 70) SHOT EPIDURAL TRAY-LF , Pack Number PAIN0362 ; 71) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0386B; 72) CONTINUOUS EPIDURAL TRAY, Pack Number PAIN0390 ; 73) SINGLE SHOT EPIDURAL T

Z-2987-2024
Recall number
Z-2987-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ0708470K , Lot Number 19ALA269 ; DYNJ0708470K , Lot Number 19ELA237 ; DYNJ0708470K , Lot Number 19FLA396 ; DYNJ0708470K , Lot Number 19GLA166 ; DYNJ0708470K , Lot Number 19HLA649 ; DYNJ0708470K , Lot Number 19ILA054 ; DYNJ0708470K , Lot Number 19JLA505 ; DYNJ0708470K , Lot Number 19KLA167 ; DYNJ0708470K , Lot Number 19LLA455 ; DYNJ0844004, Lot Number 19AKB795 ; DYNJ0844004, Lot Number 19DKC239 ; DYNJ0844004, Lot Number 19EKB799 ; DYNJ0844004, Lot Number 19FKB763 ; DYNJ0844004, Lot Number 19GKB309 ; DYNJ0844004, Lot Number 19HKC027 ; DYNJ0844004, Lot Number 19IKB582 ; DYNJ0844004, Lot Number 19JKB630 ; DYNJ0844004, Lot Number 19KKB713 ; DYNJ0934752F , Lot Number 20LLA127 ; DYNJ0934752F , Lot Number 21ALA602 ; DYNJ0934752F , Lot Number 21DLA714 ; DYNJ0934752F , Lot Number 21FLA405 ; DYNJ0934752F , Lot Number 21GLB256 ; DYNJ0934752F , Lot Number 21ILA246 ; DYNJ0934752F , Lot Number 21KLA976 ; DYNJ0934752F , Lot Number 22ALA019 ; DYNJ0934752F , Lot Number 22CLB255 ; DYNJ0934752F , Lot Number 22FLA066 ; 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DYNJRA0413B, Lot Number 20GBH708 ; DYNJRA0413B, Lot Number 20KBS442 ; DYNJRA0413B, Lot Number 20WBA666 ; DYNJRA0413B, Lot Number 20LBU660 ; DYNJRA0413B, Lot Number 21FBG031 ; DYNJRA0413B, Lot Number 22FMC186 ; DYNJRA0413B, Lot Number 22FMG924 ; DYNJRA0506A, Lot Number 19ABE030 ; DYNJRA0506A, Lot Number 19CBV429 ; DYNJRA0506A, Lot Number 19FBV291 ; DYNJRA0506A, Lot Number 19UBC261 ; DYNJRA0506A, Lot Number 19LBB195 ; DYNJRA0506A, Lot Number 20WBI799 ; DYNJRA0506A, Lot Number 20LBU416 ; DYNJRA0508 , Lot Number 18LDC366 ; DYNJRA0508 , Lot Number 19HDB088 ; DYNJRA0508 , Lot Number 20ADD292 ; DYNJRA0508 , Lot Number 20FDA387 ; DYNJRA0508 , Lot Number 20JDA109 ; DYNJRA0508 , Lot Number 21ADB235 ; DYNJRA0555 , Lot Number 22HBF866 ; DYNJRA0555 , Lot Number 22LBR977 ; DYNJRA0555 , Lot Number 23CBL284 ; DYNJRA0555 , Lot Number 23CBV260 ; DYNJRA0555 , Lot Number 23EBX300 ; DYNJRA0555 , Lot Number 23GBD403 ; DYNJRA0555 , Lot Number 23IBH382 ; DYNJRA0555 , Lot Number 23JBU347 ; DYNJRA0555 , Lot Number 19ADD201 ; DYNJRA0555 , Lot Number 19DDD449 ; DYNJRA0555 , Lot Number 19FDC623 ; DYNJRA0555 , Lot Number 19HDD621 ; DYNJRA0555 , Lot Number 19JDC313 ; DYNJRA0555 , Lot Number 19LDB165 ; DYNJRA0555 , Lot Number 20BDA347 ; DYNJRA0555 , Lot Number 20BDC891 ; DYNJRA0555 , Lot Number 20EDB763 ; DYNJRA0555 , Lot Number 20FDB737 ; DYNJRA0555 , Lot Number 20GDA559 ; DYNJRA0555 , Lot Number 20HDA079 ; DYNJRA0555 , Lot Number 21DDA946 ; DYNJRA0555 , Lot Number 21EDA464 ; DYNJRA0555 , Lot Number 21HDB810 ; DYNJRA0555 , Lot Number 21HDC639 ; DYNJRA0555 , Lot Number 21JDA489 ; DYNJRA0555 , Lot Number 21LDA709 ; DYNJRA0555 , Lot Number 22BDC535 ; DYNJRA0555 , Lot Number 22CDC391 ; DYNJRA0635 , Lot Number 18LDC802 ; DYNJRA0635 , Lot Number 19ALA377 ; DYNJRA0635 , Lot Number 19BLA494 ; DYNJRA0635 , Lot Number 19ELA012 ; DYNJRA0635 , Lot Number 19ELA593 ; DYNJRA0635 , Lot Number 19GLA520 ; DYNJRA0635 , Lot Number 19ILA334 ; DYNJRA0635 , Lot Number 19JLA264 ; DYNJRA0635 , Lot Number 20ALA847 ; DYNJRA0635 , Lot Number 20CLA622 ; 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DYNJRA0766 , Lot Number 19IBN343 ; DYNJRA0766 , Lot Number 22LBA052 ; DYNJRA0766 , Lot Number 22LBB230 ; DYNJRA0766 , Lot Number 23EBG309 ; DYNJRA0766 , Lot Number 20BBC066 ; DYNJRA0766 , Lot Number 20BBE814 ; DYNJRA0766 , Lot Number 23GBJ371 ; DYNJRA0766 , Lot Number 23JBS634 ; DYNJRA0766 , Lot Number 20HBA480 ; DYNJRA0766 , Lot Number 20HBV147 ; DYNJRA0766 , Lot Number 23LBU812 ; DYNJRA0766 , Lot Number 21ABG742 ; DYNJRA0777F, Lot Number 21GBH844 ; DYNJRA0777F, Lot Number 21HBN458 ; DYNJRA0777F, Lot Number 21JBJ833 ; DYNJRA0777F, Lot Number 21JBZ830 ; DYNJRA0777F, Lot Number 22ABA316 ; DYNJRA0777F, Lot Number 19BBG870 ; DYNJRA0777F, Lot Number 22CBW973 ; DYNJRA0777F, Lot Number 19CBS108 ; DYNJRA0777F, Lot Number 22DBN376 ; DYNJRA0777F, Lot Number 22EBJ771 ; DYNJRA0777F, Lot Number 19PBC707 ; DYNJRA0777F, Lot Number 22FBN868 ; DYNJRA0777F, Lot Number 19FBL015 ; DYNJRA0777F, Lot Number 22IBR954 ; DYNJRA0777F, Lot Number 22JBN242 ; DYNJRA0777F, Lot Number 22KBL556 ; DYNJRA0777F, Lot Number 22LBO423 ; DYNJRA0777F, Lot Number 19KBC139 ; DYNJRA0777F, Lot Number 23BBN296 ; DYNJRA0777F, Lot Number 19LBQ185 ; DYNJRA0777F, Lot Number 23DBG232 ; DYNJRA0777F, Lot Number 23DBO633 ; DYNJRA0777F, Lot Number 23FBI460 ; DYNJRA0777F, Lot Number 20BBW002 ; DYNJRA0777F, Lot Number 23FBQ027 ; DYNJRA0777F, Lot Number 20OBA254 ; DYNJRA0777F, Lot Number 23HBX553 ; DYNJRA0777F, Lot Number 20EBP539 ; DYNJRA0777F, Lot Number 20FBP407 ; DYNJRA0777F, Lot Number 23JBT365 ; DYNJRA0777F, Lot Number 23JBV384 ; DYNJRA0777F, Lot Number 20GBP113 ; DYNJRA0777F, Lot Number 20HBB356 ; DYNJRA0777F, Lot Number 20JBX794 ; DYNJRA0777F, Lot Number 20KBS563 ; DYNJRA0777F, Lot Number 21BBH582 ; DYNJRA0822A, Lot Number 21FBN503 ; DYNJRA0822A, Lot Number 21JBM403 ; DYNJRA0822A, Lot Number 21KBG795 ; DYNJRA0822A, Lot Number 21LBH377 ; DYNJRA0822A, Lot Number 22ABN336 ; DYNJRA0822A, Lot Number 22BBK018 ; DYNJRA0822A, Lot Number 19ABJ036 ; DYNJRA0822A, Lot Number 19ABW277 ; DYNJRA0822A, Lot Number 19DBR658 ; DYNJRA0822A, Lot Number 22EBQ042 ; DYNJRA0822A, Lot Number 22GBB216 ; DYNJRA0822A, Lot Number 19FBL784 ; DYNJRA0822A, Lot Number 22GBQ719 ; DYNJRA0822A, Lot Number 19GBP117 ; DYNJRA0822A, Lot Number 22IBO581 ; DYNJRA0822A, Lot Number 19IBH327 ; DYNJRA0822A, Lot Number 22KBR669 ; DYNJRA0822A, Lot Number 19JBN377 ; DYNJRA0822A, Lot Number 19KBQ196 ; DYNJRA0822A, Lot Number 23BBN236 ; DYNJRA0822A, Lot Number 23DBG234 ; DYNJRA0822A, Lot Number 23EBG321 ; DYNJRA0822A, Lot Number 23EBR040 ; DYNJRA0822A, Lot Number 20BBH743 ; DYNJRA0822A, Lot Number 20CBJ981 ; DYNJRA0822A, Lot Number 23GBI435 ; DYNJRA0822A, Lot Number 20DBH802 ; DYNJRA0822A, Lot Number 23IBG347 ; DYNJRA0822A, Lot Number 20FBD490 ; DYNJRA0822A, Lot Number 23JBQ756 ; DYNJRA0822A, Lot Number 20GBP123 ; DYNJRA0822A, Lot Number 20HBQ126 ; DYNJRA0822A, Lot Number 20IBF243 ; DYNJRA0822A, Lot Number 20JBU550 ; DYNJRA0822A, Lot Number 21ABR333 ; DYNJRA0822A, Lot Number 21CBX931 ; DYNJRA0822A, Lot Number 21FBA863 ; DYNJRA0836A, Lot Number 24BME560; DYNJRA0836A, Lot Number 19ADB345 ; DYNJRA0836A, Lot Number 19BDA752 ; DYNJRA0836A, Lot Number 19CDD119 ; DYNJRA0836A, Lot Number 19DDD452 ; DYNJRA0836A, Lot Number 19EDC939 ; DYNJRA0836A, Lot Number 19FDC113 ; DYNJRA0836A, Lot Number 19HDC474 ; DYNJRA0836A, Lot Number 19JDA309 ; DYNJRA0836A, Lot Number 19KDA732 ; DYNJRA0836A, Lot Number 20ADC997 ; DYNJRA0836A, Lot Number 20CDA353 ; DYNJRA0836A, Lot Number 20CDB711 ; DYNJRA0836A, Lot Number 20DDB245 ; DYNJRA0836A, Lot Number 20EDB493 ; DYNJRA0836A, Lot Number 20FDA982 ; DYNJRA0836A, Lot Number 20GDB190 ; DYNJRA0836A, Lot Number 20LDA045 ; DYNJRA0836A, Lot Number 20LDB700 ; DYNJRA0836A, Lot Number 21BDB021 ; DYNJRA0836A, Lot Number 21BDB748 ; DYNJRA0836A, Lot Number 21CDC517 ; DYNJRA0836A, Lot Number 21DDB255 ; DYNJRA0836A, Lot Number 21EDA469 ; DYNJRA0836A, Lot Number 21IDB841 ; DYNJRA0836A, Lot Number 21JDC356 ; DYNJRA0836A, Lot Number 21LDC133 ; DYNJRA0836A, Lot Number 22DDA296 ; DYNJRA0836A, Lot Number 22JMG065 ; DYNJRA0836A, Lot Number 23AMI489 ; DYNJRA0836A, Lot Number 23EMF962 ; DYNJRA0836A, Lot Number 23EMH061 ; DYNJRA0836A, Lot Number 23HMB994 ; DYNJRA0978A, Lot Number 18LDC115 ; DYNJRA0978A, Lot Number 19CDC648 ; DYNJRA0978A, Lot Number 19GDA566 ; DYNJRA0978A, Lot Number 19KDB078 ; DYNJRA0978A, Lot Number 20BDB500 ; DYNJRA0978A, Lot Number 20EDB408 ; DYNJRA0978A, Lot Number 20FDA075 ; DYNJRA0978A, Lot Number 20LDB613 ; DYNJRA0978A, Lot Number 21ADB509 ; DYNJRA0978A, Lot Number 21FDB023 ; DYNJRA0978A, Lot Number 21IDA315 ; DYNJRA0978A, Lot Number 21KDB447 ; DYNJRA0978A, Lot Number 22CDA922 ; DYNJRA0978A, Lot Number 22IDA804 ; DYNJRA0978A, Lot Number 22LDA279 ; DYNJRA0978A, Lot Number 23BDC012 ; DYNJRA0978A, Lot Number 23CDA630 ; DYNJRA0978A, Lot Number 23EDB931 ; DYNJRA0978A, Lot Number 23GDA932 ; DYNJRA0978A, Lot Number 23JDC308 ; DYNJRA0978A, Lot Number 24ADA047 ; DYNJRA0988 , Lot Number 18LBP310 ; DYNJRA0988 , Lot Number 19ABN818 ; DYNJRA1034 , Lot Number 19ADA564 ; DYNJRA1034 , Lot Number 19DDA190 ; DYNJRA1034 , Lot Number 19EDA882 ; DYNJRA1034 , Lot Number 19HDC038 ; DYNJRA1034 , Lot Number 19IDA833 ; DYNJRA1034 , Lot Number 19JDC586 ; DYNJRA1034 , Lot Number 19LDB160 ; DYNJRA1034 , Lot Number 20ADA649 ; DYNJRA1034 , Lot Number 20BDC831 ; DYNJRA1034 , Lot Number 20EDC301 ; DYNJRA1034 , Lot Number 20GDA875 ; DYNJRA1034 , Lot Number 20HDB810 ; DYNJRA1034 , Lot Number 20HDC047 ; DYNJRA1034 , Lot Number 20LDA063 ; DYNJRA1034 , Lot Number 20LDC051 ; DYNJRA1034 , Lot Number 21ADA815 ; DYNJRA1034 , Lot Number 21DDB594 ; DYNJRA1034 , Lot Number 21HDC360 ; DYNJRA1034 , Lot Number 21JDA388 ; DYNJRA1034 , Lot Number 21JDB558 ; DYNJRA1034 , Lot Number 21KDB526 ; DYNJRA1034 , Lot Number 22BDA350 ; DYNJRA1034 , Lot Number 22CDB340 ; DYNJRA1034 , Lot Number 22EDB265 ; DYNJRA1034 , Lot Number 22IDB714 ; DYNJRA1034 , Lot Number 22IDB920 ; DYNJRA1034 , Lot Number 22KDA539 ; DYNJRA1034 , Lot Number 22LDA118 ; DYNJRA1034 , Lot Number 23ADB146 ; DYNJRA1034 , Lot Number 23ADC022 ; DYNJRA1034 , Lot Number 23BDB896 ; DYNJRA1034 , Lot Number 23CDC558 ; DYNJRA1034 , Lot Number 23DDC303 ; DYNJRA1034 , Lot Number 23IDB418 ; DYNJRA1034 , Lot Number 23JDB931 ; DYNJRA1034 , Lot Number 24ADB162 ; DYNJRA1034 , Lot Number 24BDA117 ; DYNJRA1034 , Lot Number 24CDA047 ; DYNJRA1730A, Lot Number 21HBC087 ; DYNJRA1730A, Lot Number 21HBP692 ; DYNJRA1730A, Lot Number 21IBD290 ; DYNJRA1730A, Lot Number 21KBN724 ; DYNJRA1730A, Lot Number 21LBP421 ; DYNJRA1730A, Lot Number 22FBD227 ; DYNJRA1730A, Lot Number 22GBI812 ; DYNJRA1730A, Lot Number 22HBP553 ; DYNJRA1730A, Lot Number 23BBN319 ; DYNJRA1730A, Lot Number 23CBE620 ; DYNJRA1730A, Lot Number 23GBJ369 ; DYNJRA1730A, Lot Number 21EBG306 ; DYNJRA1730A, Lot Number 21EBI290 ; DYNJRA9028 , Lot Number 22FBF136 ; DYNJRA9028 , Lot Number 22IBA613 ; DYNJRA9028 , Lot Number 22KBI013 ; DYNJRA9028 , Lot Number 22KBR202 ; DYNJRA9028 , Lot Number 23ABK250 ; DYNJRA9028 , Lot Number 23BBC998 ; DYNJRA9028 , Lot Number 23CBV355 ; DYNJRA9028 , Lot Number 23EBA918 ; DYNJRA9028 , Lot Number 23EBQ107 ; DYNJRA9028 , Lot Number 23GBC535 ; DYNJRA9028 , Lot Number 23HBS638 ; 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DYNJRA9036H, Lot Number 24ABU128 ; DYNJRA9036H, Lot Number 21CBT177 ; DYNJRA9036H, Lot Number 21FBD294 ; DYNJRA9037 , Lot Number 21IBU216 ; DYNJRA9037 , Lot Number 21KBU090 ; DYNJRA9037 , Lot Number 21KBU293 ; DYNJRA9037 , Lot Number 22IBI417 ; DYNJRA9037 , Lot Number 22LBB114 ; DYNJRA9037 , Lot Number 23DBA176 ; DYNJRA9037 , Lot Number 23EBQ390 ; DYNJRA9037 , Lot Number 23GBB280 ; DYNJRA9037 , Lot Number 23HBA395 ; DYNJRA9037 , Lot Number 20FBB066 ; DYNJRA9037 , Lot Number 23KBA132 ; DYNJRA9037 , Lot Number 20IBF928 ; DYNJRA9037 , Lot Number 20KBS688 ; DYNJRA9037 , Lot Number 21ABB498 ; PAIN0012 , Lot Number 19ABK914 ; PAIN0012 , Lot Number 19CBN825 ; PAIN0012 , Lot Number 19DBV336 ; PAIN0012 , Lot Number 19FBJ283 ; PAIN0012 , Lot Number 19GBP113 ; PAIN0012 , Lot Number 19HBK062 ; PAIN0012 , Lot Number 19JBX396 ; PAIN0012 , Lot Number 19LBX154 ; PAIN0024D, Lot Number 19ADA925 ; PAIN0024D, Lot Number 19BDA220 ; PAIN0024D, Lot Number 19CDB093 ; PAIN0024D, Lot Number 19DDB581 ; PAIN0024D, Lot Number 19EDA454 ; PAIN0024D, Lot Number 19GDA745 ; PAIN0024D, Lot Number 19HDA623 ; PAIN0024D, Lot Number 19JDC165 ; PAIN0024D, Lot Number 20ADC489 ; PAIN0024D, Lot Number 20EDB078 ; PAIN0024D, Lot Number 20JDB296 ; PAI

Distribution pattern

Worldwide distribution.

device · product 8 of 81

Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137

Z-2988-2024
Recall number
Z-2988-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJRA0377B, Lot Number 19DDB791 ; DYNJRA0377B, Lot Number 21KDA359 ; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243

Distribution pattern

Worldwide distribution.

device · product 9 of 81

Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026

Z-2989-2024
Recall number
Z-2989-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJRA9026 , Lot Number 22EBN191 ; DYNJRA9026 , Lot Number 22LBC356 ; DYNJRA9026 , Lot Number 23ABN403 ; DYNJRA9026 , Lot Number 23CBP475 ; DYNJRA9026 , Lot Number 23DBG934 ; DYNJRA9026 , Lot Number 23EBH050 ; DYNJRA9026 , Lot Number 23JBS641 ; DYNJRA9026 , Lot Number 23KBJ179 ; DYNJRA9026 , Lot Number 23LBU686 ; DYNJRA9026 , Lot Number 19ADC324 ; DYNJRA9026 , Lot Number 19ADD208 ; DYNJRA9026 , Lot Number 19LDA087 ; DYNJRA9026 , Lot Number 19LDB132 ; DYNJRA9026 , Lot Number 20ADC808 ; DYNJRA9026 , Lot Number 20BDA346 ; DYNJRA9026 , Lot Number 20BDB555 ; DYNJRA9026 , Lot Number 20CDB731 ; DYNJRA9026 , Lot Number 20EDC526 ; DYNJRA9026 , Lot Number 20GDA908 ; DYNJRA9026 , Lot Number 20IDA046 ; DYNJRA9026 , Lot Number 20IDA621 ; DYNJRA9026 , Lot Number 20LDB113 ; DYNJRA9026 , Lot Number 20LDB323 ; DYNJRA9026 , Lot Number 21BDA498 ; DYNJRA9026 , Lot Number 21DDA458 ; DYNJRA9026 , Lot Number 21DDA663 ; DYNJRA9026 , Lot Number 21HDC456 ; DYNJRA9026 , Lot Number 21JDB091 ; DYNJRA9026 , Lot Number 21KDC632 ; DYNJRA9026 , Lot Number 21LDA581 ; DYNJRA9026 , Lot Number 21LDB014 ; DYNJRA9026 , Lot Number 22BDA209 ; DYNJRA9026 , Lot Number 22BDC191 ; DYNJRA9026 , Lot Number 22CDA655 ; DYNJRA9026 , Lot Number 22CDC010 ; DYNJRA9026 , Lot Number 22ILB005 ; DYNJRA9026 , Lot Number 22KLA115

Distribution pattern

Worldwide distribution.

device · product 10 of 81

Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ; 5) KIT ANGIO CSTM-SETON, Pack Number 143267; 6) SYR- VA HOSPITAL, Pack Number 144684; 7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A; 8) CSTM MANIFOLD KIT , Pack Number SAMPC0547; 9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ; 10) CSTM MANIFOLD KIT , Pack Number VASC1130

Z-2990-2024
Recall number
Z-2990-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

129736 , Lot Number 20DKA054 ; 132701, Lot Number 24ADB481; 132701, Lot Number 24ADA120; 132701, Lot Number 23GDC081; 132701, Lot Number 23DDC268; 132701, Lot Number 23CDC677; 132701, Lot Number 22LDA569; 132701, Lot Number 22IDC180; 132701, Lot Number 22IDA238; 132701, Lot Number 22DDB501; 132701, Lot Number 22DDA530; 132701, Lot Number 22ADB638; 132701, Lot Number 21KDB209; 132701, Lot Number 21KDA233; 132701, Lot Number 21JDA611; 132701, Lot Number 21FDC090; 132701, Lot Number 21EDB524; 132701, Lot Number 21CDB488; 132701, Lot Number 20LDB085; 132701, Lot Number 20KDA727; 132701, Lot Number 20FDC203; 132701, Lot Number 20BDB590; 132701, Lot Number 20BDA433; 134085 , Lot Number 22BBZ656Z; 142643 , Lot Number 22NBF339Z; 143267, Lot Number 22GMA268; 144684, Lot Number 24AMB389; 144684, Lot Number 23LMG949; 144684, Lot Number 23KMJ307; 144684, Lot Number 23HMI452; 144684, Lot Number 23GMB839; 144684, Lot Number 23FMI280; 144684, Lot Number 23DMH268; 144684, Lot Number 23CMH563; 144684, Lot Number 23BMF752; 144684, Lot Number 22LMA051; 144684, Lot Number 22IMA306; CDS985003A, Lot Number 24CMC421; CDS985003A, Lot Number 24CMC421; CDS985003A , Lot Number 21GBM644 ; CDS985003A , Lot Number 19BBN133 ; CDS985003A , Lot Number 19CBQ620 ; CDS985003A , Lot Number 19EBW590 ; CDS985003A , Lot Number 19GBB647 ; CDS985003A , Lot Number 19LBU108 ; CDS985003A , Lot Number 20ABT969 ; CDS985003A , Lot Number 20ABW952 ; CDS985003A , Lot Number 20DBD342 ; CDS985003A , Lot Number 20EBS254 ; CDS985003A , Lot Number 20GBJ904 ; CDS985003A , Lot Number 20IBG340 ; CDS985003A , Lot Number 20JBP424 ; CDS985003A , Lot Number 20KBU982 ; CDS985003A , Lot Number 21CBW933 ; CDS985003A , Lot Number 21EBE602 ; CDS985003A , Lot Number 22CMA036 ; CDS985003A , Lot Number 22DMI553 ; CDS985003A , Lot Number 23DMH255 ; CDS985003A , Lot Number 23DMH760 ; CDS985003A , Lot Number 23FMF204 ; CDS985003A , Lot Number 23GMB004 ; CDS985003A , Lot Number 23GMI569 ; CDS985003A , Lot Number 23JMJ652 ; CDS985003A , Lot Number 24AMB671 ; SAMPC0547, Lot Number 19BDB826 ; VASC1074 , Lot Number 22BBR869 ; VASC1130 , Lot Number 20LME799

Distribution pattern

Worldwide distribution.

device · product 11 of 81

Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223

Z-2991-2024
Recall number
Z-2991-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ41223, Lot Number 21HBU861 ; DYNJ41223, Lot Number 21KBA848 ; DYNJ41223, Lot Number 21KBA910 ; DYNJ41223, Lot Number 22ABA546 ; DYNJ41223, Lot Number 22MBA262 ; DYNJ41223, Lot Number 19BBC903 ; DYNJ41223, Lot Number 19CBO901 ; DYNJ41223, Lot Number 19DBW422 ; DYNJ41223, Lot Number 22HBY065 ; DYNJ41223, Lot Number 19HBD957 ; DYNJ41223, Lot Number 19HBJ856 ; DYNJ41223, Lot Number 19IBT476 ; DYNJ41223, Lot Number 22KBU048 ; DYNJ41223, Lot Number 19VBD385 ; DYNJ41223, Lot Number 19LBF954 ; DYNJ41223, Lot Number 23EBC280 ; DYNJ41223, Lot Number 23FBA251 ; DYNJ41223, Lot Number 20BBP883 ; DYNJ41223, Lot Number 20CBI263 ; DYNJ41223, Lot Number 23JBC138 ; DYNJ41223, Lot Number 23KBO541 ; DYNJ41223, Lot Number 20IBJ759 ; DYNJ41223, Lot Number 20JBE058 ; DYNJ41223, Lot Number 20XBF374

Distribution pattern

Worldwide distribution.

device · product 12 of 81

Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 61) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 67) CATH PACK-LF, Pack Number DYNJ0367643Q ; 68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ; 75) ANGIO PACK-LF , Pack Number DYNJ0373279M ; 76) INTERVENTIO

Z-2992-2024
Recall number
Z-2992-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

00-398281J , Lot Number 19FBL693 ; 00-398281J , Lot Number 19HBQ768 ; 00-398281J , Lot Number 19IBJ984 ; 00-398281J , Lot Number 19JBM853 ; 00-398650AG, Lot Number 19ABM946 ; 00-398650AG, Lot Number 19BBS748 ; 00-398650AG, Lot Number 19CBJ825 ; 00-398650AG, Lot Number 19DBR708 ; 00-398650AG, Lot Number 19FBR243 ; 00-398650AG, Lot Number 19IBV635 ; 00-398650AG, Lot Number 19KBL462 ; 00-398650AG, Lot Number 20MBA140 ; 00-398650AG, Lot Number 20EBE408 ; 00-398650AG, Lot Number 20FBJ771 ; 00-398650AG, Lot Number 20HBI575 ; 00-398650AG, Lot Number 20JBJ100 ; 00-398650AG, Lot Number 21ABP363 ; 00-398650AG, Lot Number 21ABQ027 ; 00-398650AI, Lot Number 21FBT441 ; 00-398650AI, Lot Number 21IBH355 ; 00-398650AI, Lot Number 21KBM869 ; 00-398650AI, Lot Number 21LBH937 ; 00-398650AI, Lot Number 22BBA596 ; 00-398650AI, Lot Number 22CBY494 ; 00-398650AI, Lot Number 22DBQ496 ; 00-398650AI, Lot Number 22FBL546 ; 00-398650AI, Lot Number 22GBJ321 ; 00-398650AI, Lot Number 22JBE607 ; 00-398650AI, Lot Number 22JBE609 ; 00-398650AI, Lot Number 21EBB527 ; 00-398712S , Lot Number 19KMA101 ; 00-398712S , Lot Number 19LMB722 ; 00-398712S , Lot Number 20CMA260 ; 00-398712S , Lot Number 20CMC911 ; 00-398712S , Lot Number 20FMA921 ; 00-398712S , Lot Number 20GMB435 ; 00-398712S , Lot Number 20IMA653 ; 00-398712S , Lot Number 20KMA809 ; 00-398712S , Lot Number 20LMD895 ; 00-398712S , Lot Number 21CMD722 ; 00-398712S , Lot Number 21EMF323 ; 00-398712S , Lot Number 21HMB142 ; 00-398712S , Lot Number 21IMB825 ; 00-398712S , Lot Number 21JMH910 ; 00-398712S , Lot Number 21LMG148 ; 00-398712S , Lot Number 22BMH320 ; 00-398712S , Lot Number 22DME594 ; 00-398712S , Lot Number 22HMI166 ; 00-398712S , Lot Number 22JME059 ; 00-398712S , Lot Number 23AME236 ; 00-398712S , Lot Number 23DME416 ; 00-398712S , Lot Number 23FMG905 ; 00-398712S , Lot Number 23IMF984 ; 00-398712S , Lot Number 23KMF990 ; 00-398712S , Lot Number 19BKB212 ; 00-398712S , Lot Number 19CKB198 ; 00-398712S , Lot Number 19EKB257 ; 00-398712S , Lot Number 19GKC485 ; 00-398712S , Lot Number 19IKA568 ; 00-398712S , Lot Number 19IKB991 ; 00-398725AM, Lot Number 21FBJ550 ; 00-398725AM, Lot Number 19IBJ529 ; 00-398725AM, Lot Number 19KBS571 ; 00-398725AM, Lot Number 19KBU397 ; 00-398725AM, Lot Number 20BBE698 ; 00-398725AM, Lot Number 20CBG353 ; 00-398725AM, Lot Number 20DBI198 ; 00-398725AM, Lot Number 20FBB296 ; 00-398725AM, Lot Number 20FBC302 ; 00-398725AM, Lot Number 20GBF723 ; 00-398725AM, Lot Number 20HBM698 ; 00-398725AM, Lot Number 20LBR908 ; 00-398725AM, Lot Number 21BBE202 ; 00-398725AM, Lot Number 21DBD638 ; 00-399360K , Lot Number 21VBC685 ; 00-399360K , Lot Number 23FBU384 ; 00-399360K , Lot Number 23IBA381 ; 00-399360K , Lot Number 23KBE043 ; 00-399360K , Lot Number 23LBR853 ; 00-399734N , Lot Number 23JBU818 ; 00-399734N , Lot Number 23KBI990 ; 00-399734N , Lot Number 23LBV170 ; 00-399734N , Lot Number 19ADB519 ; 00-399734N , Lot Number 19BDB357 ; 00-399734N , Lot Number 19DDA161 ; 00-399734N , Lot Number 19EDA281 ; 00-399734N , Lot Number 19EDC270 ; 00-399734N , Lot Number 19GDA275 ; 00-399734N , Lot Number 19IDA132 ; 00-399734N , Lot Number 19LMA267 ; 00-399734N , Lot Number 20BMA475 ; 00-399734N , Lot Number 20DMA774 ; 00-399734N , Lot Number 20GMB326 ; 00-399734N , Lot Number 20IMD767 ; 00-399734N , Lot Number 20JMC215 ; 00-399734N , Lot Number 21DMA867 ; 00-399734N , Lot Number 21DME739 ; 00-399734N , Lot Number 21FMF556 ; 00-399734N , Lot Number 21IMA047 ; 00-399734N , Lot Number 21JME290 ; 00-399734N , Lot Number 21JMH037 ; 00-399734N , Lot Number 22CMF020 ; 00-399734N , Lot Number 22DMF495 ; 00-399734N , Lot Number 22GMB900 ; 00-399734N , Lot Number 22IMA125 ; 00-399734N , Lot Number 22JME374 ; 00-399734N , Lot Number 22LMB989 ; 00-399734N , Lot Number 23DMA849 ; 00-399734N , Lot Number 23EMC285 ; 00-399734N , Lot Number 23EMJ483 ; 00-399983Q , Lot Number 19BBE921 ; 00-399983Q , Lot Number 19CBY031 ; 00-399983Q , Lot Number 19PBC257 ; 00-399983Q , Lot Number 19FBR534 ; 00-399983Q , Lot Number 19HBF178 ; 00-399983Q , Lot Number 19KBF830 ; 00-399983Q , Lot Number 19LBP680 ; 00-399983Q , Lot Number 20ABX119 ; 00-399983Q , Lot Number 20CBX476 ; 00-399983Q , Lot Number 20EMA308 ; 00-399983Q , Lot Number 20GMA221 ; 00-399983Q , Lot Number 20HMD089 ; 00-399983Q , Lot Number 20JMA848 ; 00-399983Q , Lot Number 20JMC961 ; 00-399983Q , Lot Number 21AMB499 ; 00-399983R , Lot Number 21DMF325 ; 00-399983R , Lot Number 21GMD901 ; 00-399983R , Lot Number 21HMA462 ; 00-399983R , Lot Number 21KMF309 ; 00-399983R , Lot Number 21KMH211 ; 00-399983R , Lot Number 21LMA509 ; 00-399983R , Lot Number 22AME571 ; 00-399983R , Lot Number 22EMC467 ; 00-399983R , Lot Number 22HME724 ; 00-399983R , Lot Number 22KMB997 ; 00-399983R , Lot Number 23AMA130 ; 00-399983R , Lot Number 23CMA230 ; 00-400065K , Lot Number 21FBR263 ; 00-400065K , Lot Number 21HBB836 ; 00-400065K , Lot Number 21JBL879 ; 00-400065K , Lot Number 21KBF878 ; 00-400065K , Lot Number 21LBU544 ; 00-400065K , Lot Number 22BBG118 ; 00-400065K , Lot Number 19ABB720 ; 00-400065K , Lot Number 22CBU488 ; 00-400065K , Lot Number 19BBQ915 ; 00-400065K , Lot Number 19CBM065 ; 00-400065K , Lot Number 22DBP187 ; 00-400065K , Lot Number 19DBM042 ; 00-400065K , Lot Number 22EBP317 ; 00-400065K , Lot Number 19EBX671 ; 00-400065K , Lot Number 22HBF260 ; 00-400065K , Lot Number 19GBN148 ; 00-400065K , Lot Number 22KBG632 ; 00-400065K , Lot Number 19JBB584 ; 00-400065K , Lot Number 19JBI267 ; 00-400065K , Lot Number 22LBO309 ; 00-400065K , Lot Number 23ABG526 ; 00-400065K , Lot Number 23BBQ040 ; 00-400065K , Lot Number 19KBY541 ; 00-400065K , Lot Number 23CBJ011 ; 00-400065K , Lot Number 20MBA423 ; 00-400065K , Lot Number 20CBC516 ; 00-400065K , Lot Number 20DBM271 ; 00-400065K , Lot Number 20FBD765 ; 00-400065K , Lot Number 20GBH479 ; 00-400065K , Lot Number 20HBW054 ; 00-400065K , Lot Number 20JBN060 ; 00-400065K , Lot Number 20KBW249 ; 00-400065K , Lot Number 21BBD722 ; 00-400065K , Lot Number 21CBV490 ; 00-400069F , Lot Number 21GBJ540 ; 00-400069F , Lot Number 21HBN535 ; 00-400069F , Lot Number 21JBV864 ; 00-400069F , Lot Number 19KBY112 ; 00-400069F , Lot Number 19KBZ300 ; 00-400069F , Lot Number 19LBT262 ; 00-400069F , Lot Number 20ABA121 ; 00-400069F , Lot Number 20ABE706 ; 00-400069F , Lot Number 20FBH567 ; 00-400069F , Lot Number 20FBU536 ; 00-400069F , Lot Number 20HBM357 ; 00-400069F , Lot Number 20IBI988 ; 00-400069F , Lot Number 20JBE618 ; 00-400069F , Lot Number 20LBM288 ; 00-400069F , Lot Number 20LBM394 ; 00-400069F , Lot Number 20LBR652 ; 00-400069F , Lot Number 21ABB713 ; 00-400069F , Lot Number 21CBR762 ; 00-400123AC, Lot Number 19ABQ452 ; 00-400123AC, Lot Number 19BBN072 ; 00-400123AC, Lot Number 19BBT797 ; 00-400123AC, Lot Number 19CBR393 ; 00-400123AC, Lot Number 19DBP114 ; 00-400123AC, Lot Number 19EBR874 ; 00-400123AC, Lot Number 19EBZ557 ; 00-400123AC, Lot Number 19GBW344 ; 00-400123AC, Lot Number 19VBA449 ; 00-400123AC, Lot Number 19LBE973 ; 00-400123AC, Lot Number 20BBI940 ; 00-400123AC, Lot Number 20CBU720 ; 00-400123AC, Lot Number 20FBC048 ; 00-400123AD, Lot Number 21GBB662 ; 00-400123AD, Lot Number 21HBE405 ; 00-400123AD, Lot Number 21JBT553 ; 00-400123AD, Lot Number 21JBT555 ; 00-400123AD, Lot Number 21LBM691 ; 00-400123AD, Lot Number 22ABN198 ; 00-400123AD, Lot Number 22EBG139 ; 00-400123AD, Lot Number 22GBB778 ; 00-400123AD, Lot Number 20IBL629 ; 00-400123AD, Lot Number 20JBL358 ; 00-400123AD, Lot Number 21ABG411 ; 00-400123AD, Lot Number 21BBD488 ; 00-400123AD, Lot Number 21CBJ466 ; 00-400290D , Lot Number 21JBL730 ; 00-400290D , Lot Number 21JBL760 ; 00-400290D , Lot Number 22BBL397 ; 00-400290D , Lot Number 22DBD105 ; 00-400290D , Lot Number 22HBX245 ; 00-400290D , Lot Number 22IBJ158 ; 00-400290D , Lot Number 23ABM361 ; 00-400290D , Lot Number 23FBB540 ; 00-400290D , Lot Number 23HBW414 ; 00-400290D , Lot Number 23KBQ874 ; 00-400305Q , Lot Number 21FBH829 ; 00-400305Q , Lot Number 19BBI732 ; 00-400305Q , Lot Number 19CBT638 ; 00-400305Q , Lot Number 19FBK838 ; 00-400305Q , Lot Number 19HBQ608 ; 00-400305Q , Lot Number 19JBF448 ; 00-400305Q , Lot Number 19KBK353 ; 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DYNJ0160556D , Lot Number 22JDA514 ; DYNJ0160556D , Lot Number 23BDA568 ; DYNJ0161241F , Lot Number 20BDA735 ; DYNJ0161241F , Lot Number 20CDB736 ; DYNJ0161241F , Lot Number 20GDB449 ; DYNJ0161241F , Lot Number 20IDA082 ; DYNJ0161241F , Lot Number 20KDA354 ; DYNJ0161241F , Lot Number 20LDB702 ; DYNJ0161241F , Lot Number 21FDA333 ; DYNJ0161241F , Lot Number 21FDC117 ; DYNJ0161241F , Lot Number 21GDD174 ; DYNJ0161241F , Lot Number 21IDB617 ; DYNJ0161241F , Lot Number 21KDC480 ; DYNJ0161241F , Lot Number 22CDA923 ; DYNJ0161241F , Lot Number 22FDB089 ; DYNJ0161241F , Lot Number 22GDB301 ; DYNJ0161241F , Lot Number 22HDA066 ; DYNJ0161241F , Lot Number 22IDA273 ; DYNJ0161241F , Lot Number 22KDB022 ; DYNJ0161241F , Lot Number 23ADB121 ; DYNJ0161241F , Lot Number 23ADB642 ; DYNJ0161241F , Lot Number 23CDC525 ; DYNJ0161241F , Lot Number 23FDB083 ; DYNJ0161241F , Lot Number 23HDB338 ; DYNJ0161241F , Lot Number 23IDC123 ; DYNJ0161241F , Lot Number 23JDB460 ; DYNJ0161241F , Lot Number 23LDC122 ; DYNJ0161241F , Lot Number 24CDA742 ; DYNJ0165039M , Lot Number 20LMC012 ; DYNJ0165039M , Lot Number 21BMB999 ; DYNJ0165039M , Lot Number 21CMA971 ; DYNJ0165039M , Lot Number 19AKA997 ; DYNJ0165039M , Lot Number 19AKD298 ; DYNJ0165039M , Lot Number 19CKA034 ; DYNJ0165039M , Lot Number 19DKD120 ; DYNJ0165039M , Lot Number 19FKC588 ; DYNJ0165039M , Lot Number 19HKB202 ; DYNJ0165039M , Lot Number 19IKB966 ; DYNJ0165039M , Lot Number 19KKB215 ; DYNJ0165039M , Lot Number 20AKC217 ; DYNJ0165039M , Lot Number 20DKA921 ; DYNJ0165039M , Lot Number 20GKA483 ; DYNJ0165039N , Lot Number 21GMA437 ; DYNJ0165039N , Lot Number 21IMB664 ; DYNJ0165039N , Lot Number 21JME773 ; DYNJ0165039N , Lot Number 21KMC056 ; DYNJ0165039N , Lot Number 22AMB945 ; DYNJ0165039N , Lot Number 22DMD177 ; DYNJ0165039N , Lot Number 22EMA803 ; DYNJ0165039N , Lot Number 22GMG452 ; DYNJ0165039N , Lot Number 22IMF336 ; DYNJ0165039N , Lot Number 22IMG205 ; DYNJ0165039N , Lot Number 22KMC942 ; DYNJ0165039N , Lot Number 23AMA481 ; DYNJ0165039N , Lot Number 23BMB999 ; DYNJ0165039N , Lot Number 23CMA964 ; DYNJ0165039N , Lot Number 23CME707 ; DYNJ0165039N , Lot Number 23DME460 ; DYNJ0165039N , Lot Number 23EMH215 ; DYNJ0194989AF, Lot Number 19BKC239 ; DYNJ0194989AF, Lot Number 19CKD939 ; DYNJ0194989AF, Lot Number 19EKC339 ; DYNJ0194989AG, Lot Number 21HMF548 ; DYNJ0194989AG, Lot Number 21IMF017 ; DYNJ0194989AG, Lot Number 21KMF814 ; DYNJ0194989AG, Lot Number 22AMF939 ; DYNJ0194989AG, Lot Number 22CMB010 ; DYNJ0201109AG, Lot Number 21GBH202 ; DYNJ0201109AG, Lot Number 21HBC779 ; DYNJ0201109AG, Lot Number 21IBR980 ; DYNJ0201109AG, Lot Number 21JBY989 ; DYNJ0201109AG, Lot Number 21VBC419 ; DYNJ0201109AG, Lot Number 22ABR950 ; DYNJ0201109AG, Lot Number 22BBQ567 ; DYNJ0201109AG, Lot Number 21CBO991 ; DYNJ0201109AG, Lot Number 21DBA870 ; DYNJ0201109AG, Lot Number 21DBS763 ; DYNJ0201109AG, Lot Number 21EBS525 ; DYNJ0220880V , Lot Number 21FLA083 ; DYNJ0220880V , Lot Number 21ILA147 ; DYNJ0220880V , Lot Number 21KLA059 ; DYNJ0220880V , Lot Number 22ALA070 ; DYNJ0220880V , Lot Number 22ALA656 ; DYNJ0220880V , Lot Number 22ALA849 ; DYNJ0220880V , Lot Number 22DLA707 ; DYNJ0220880V , Lot Number 22FLA700 ; DYNJ0220880V , Lot Number 22HLA272 ; DYNJ0220880V , Lot Number 22ILA188 ; DYNJ0220880V , Lot Number 22ILA237 ; DYNJ0220880V , Lot Number 22ILA641 ; DYNJ0220880V , Lot Number 22JLA662 ; DYNJ0220880V , Lot Number 22KLA379 ; DYNJ0220880V , Lot Number 22KLA836 ; DYNJ0220880V , Lot Number 22KLA939 ; DYNJ0220880V , Lot Number 22LLA399 ; DYNJ0220880V , Lot Number 23HLA505 ; DYNJ0220880V , Lot Number 23HLB257 ; DYNJ0220880V , Lot Number 23ILB004 ; DYNJ0220880V , Lot Number 23JLA021 ; DYNJ0220880V , Lot Number 23JLA059 ; DYNJ0220880V , Lot Number 23KLA121 ; DYNJ0220880V , Lot Number 23KLA231 ; DYNJ0220880V , Lot Number 23KLA582 ; DYNJ0220880V , Lot Number 23LLA817 ; DYNJ0241256L , Lot Number 19CKA699 ; DYNJ0241256L , Lot Number 19GKC060 ; DYNJ0241256L , Lot Number 19HKC738 ; DYNJ0241256L , Lot Number 19IKB047 ; DYNJ0241256L , Lot Number 19KKA067 ; DYNJ0281048I , Lot Number 19EBN094 ; DYNJ0281048I , Lot Number 19FBA415 ; DYNJ0281048I , Lot Number 19HBB404 ; DYNJ0281048I , Lot Number 19TBA959 ; DYNJ0281048I , Lot Number 19KBB264 ; DYNJ0281048I , Lot Number 19KBM898 ; DYNJ0281048I , Lot Number 19LBX426 ; DYNJ0281048I , Lot Number 20BBL584 ; DYNJ0281048I , Lot Number 20BBY732 ; DYNJ0281048I , Lot Number 20DBA803 ; DYNJ0281048I , Lot Number 20EMB802 ; DYNJ0281048I , Lot Number 20GMA065 ; DYNJ0281048I , Lot Number 20GMD073 ; DYNJ0281048I , Lot Number 20IMA406 ; DYNJ0281048I , Lot Number 20KMB107 ; DYNJ0281048I , Lot Number 20LMB915 ; DYNJ0281048I , Lot Number 20LMF792 ; DYNJ0281048I , Lot Number 21DMB584 ; DYNJ0281048I , Lot Number 21DMF017 ; DYNJ0281048I , Lot Number 21FMD971 ; DYNJ0281048I , Lot Number 21HMA956 ; DYNJ0281048I , Lot Number 21JME699 ; DYNJ0281048I , Lot Number 21LMA239 ; DYNJ0281048I , Lot Number 18LKD415 ; DYNJ0281048I , Lot Number 19BKB712 ; DYNJ0281048I , Lot Number 19CKB580 ; DYNJ0281048I , Lot Number 19EKB261 ; DYNJ0290716L , Lot Number 21FBQ865 ; DYNJ0290716L , Lot Number 21HBK454 ; DYNJ0290716L , Lot Number 21IBL466 ; DYNJ0290716L , Lot Number 21LBL165 ; DYNJ0290716L , Lot Number 21EBL353 ; DYNJ0298504AG, Lot Number 19AKC049 ; DYNJ0298504AG, Lot Num

Distribution pattern

Worldwide distribution.

device · product 13 of 81

Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD; 6) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 7) BIOPSY TRAY, Pack Number DYNDH1129; 8) ARTHROGRAM TRAY, Pack Number DYNDH1134; 9) BRISTOL MYELOGRAM, Pack Number DYNDH1228; 10) LUMBAR TRAY, Pack Number DYNDH1540A; 11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827; 12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932; 13) BIOPSY PACK, Pack Number DYNDL1462B; 14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q; 15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G; 16) CATH LAB PACK-LF, Pack Number DYNJ0173400P; 17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 18) PICC LINE PACK-LF, Pack Number DYNJ0275614F; 19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L; 20) SPECIAL PROCEDURE ANGIO PACK, Pack Number DYNJ04386U; 21) RADIOLOGY PACK, Pack Number DYNJ04562S; 22) IR PACK, Pack Number DYNJ04674U; 23) IR PACK, Pack Number DYNJ04674UH; 24) LEFT HEART PACK-LF, Pack Number DYNJ0490280PH; 25) LT HEART/ANGIOGRAPHY PACK-LF, Pack Number DYNJ0537652AG; 26) SM CARDIAC CATH PACK-LF , Pack Number DYNJ0621195TH; 27) CATH LAB PACK-LF, Pack Number DYNJ0755738R; 28) CARDIAC CATH PACK-LF, Pack Number DYNJ0781476AAH ; 29) CARDIAC CATH PACK-LF, Pack Number DYNJ0781918NH; 30) CATH LAB PACK , Pack Number DYNJ07919GH; 31) PACEMAKER PACK-LF , Pack Number DYNJ0830939ACH ; 32) CARDIAC CATH PACK-LF, Pack Number DYNJ0843627G ; 33) PICC INSERTION PACK-LF, Pack Number DYNJ0880659D; 34) PEDS HEART CATH PACK-LF, Pack Number DYNJ0897998D; 35) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414BH; 36) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414CH; 37) CATH LAB PACK , Pack Number DYNJ10117JH; 38) CARDIAC CATH PACK, Pack Number DYNJ17081S; 39) DEPAUL ANGIO PROCEDURE PACK, Pack Number DYNJ19937I; 40) PV/PTA TRAY-RF, Pack Number DYNJ21944VH; 41) ANGIO TRAY, Pack Number DYNJ23438M; 42) ANGIO TRAY, Pack Number DYNJ23438N; 43) ANGIO TRAY, Pack Number DYNJ23438O; 44) ADULT CARDIAC CATH PACK, Pack Number DYNJ23455Q; 45) VIR PACK, Pack Number DYNJ23499MH; 46) HEART CATH-SMH, Pack Number DYNJ24483FH; 47) CATH LAB PACK , Pack Number DYNJ24802PH; 48) ANGIO DRAPE PACK, Pack Number DYNJ24806KH; 49) RADIOLOGY STD TRAY, Pack Number DYNJ25029RH; 50) CARDIAC CATH PACK, Pack Number DYNJ26305N; 51) DIAGNOSTIC ADULT-LF , Pack Number DYNJ27239DH; 52) HEART CATH LT PACK, Pack Number DYNJ31282I; 53) ANGIO PACK, Pack Number DYNJ31339I; 54) CARDIAC CATH PACK, Pack Number DYNJ31847I; 55) NEURO ANGIO TRAY-LF, Pack Number DYNJ34882M; 56) HEART CATH II PACK CHS-LF, Pack Number DYNJ35605M; 57) ISSAQUA CATH/IR PACK, Pack Number DYNJ36738G; 58) PEDS CARDIAC PACK, Pack Number DYNJ37418MH; 59) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050F; 60) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050FH; 61) SPECIAL PROCEDURE PACK, Pack Number DYNJ38314G; 62) MINOR SPECIAL PROCEDURE PACK, Pack Number DYNJ38326G; 63) CARDIAC CATH PACK, Pack Number DYNJ38866F; 64) PERM CATH TRAY, Pack Number DYNJ40423AH; 65) O R EMERGENCY PACK, Pack Number DYNJ40460CH; 66) CARDIAC CATH PACK, Pack Number DYNJ40511M; 67) CATH LAB PACK, Pack Number DYNJ40961A; 68) CARDIAC CATH TRAY, Pack Number DYNJ41050C; 69) CATH LAB PACK, Pack Number DYNJ43469D; 70) PK, RADIOLOGY, Pack Number DYNJ43816B; 71) CARDIAC CATH TRAY, Pack Number DYNJ45323F; 72) LEFT HEART, Pack Number DYNJ45984I; 73) CATH LAB PROCEDURE, Pack Number DYNJ46353F; 74) ANGIO PACK, Pack Number DYNJ46401B; 75) CARDIAC CATH TRAY, Pack Number DYNJ46402A; 76) CARDIAC CATH TRAY, Pack Number DYNJ46419C; 77) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646D; 78) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646F; 79) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646G; 80) NEURO

Z-2993-2024
Recall number
Z-2993-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

00-RDF036O, Lot Number 24BMG670; 00-RDF036OH, Lot Number 24BMG670; 00-RDF036OH, Lot Number 22FMH197 ; 00-RDF036OH, Lot Number 22IMC476 ; 00-RDF036OH, Lot Number 22JMD690 ; 00-RDF036OH, Lot Number 22KMB816 ; 00-RDF036OH, Lot Number 22LMB962 ; 00-RDF036OH, Lot Number 23BMA905 ; 00-RDF036OH, Lot Number 23BMH681 ; 00-RDF036OH, Lot Number 23CMG412 ; 00-RDF036OH, Lot Number 23DMI750 ; 00-RDF036OH, Lot Number 23IMD552 ; 00-RDF036OH, Lot Number 23KMD849 ; 0M-CP31433J, Lot Number 24DBD373; ART1210, Lot Number 2023121890; BM17BAD, Lot Number 22FBA406; BM17BAD, Lot Number 22EBJ428; CVI4970, Lot Number 2023121880; DYNDH1129, Lot Number 2019012450; DYNDH1134, Lot Number 2019012450; DYNDH1228, Lot Number 23JBW148; DYNDH1228, Lot Number 23HBW751; DYNDH1228, Lot Number 23FBU652; DYNDH1228, Lot Number 23DBK822; DYNDH1228, Lot Number 23JBW148; DYNDH1228, Lot Number 23HBW751; DYNDH1228, Lot Number 23FBU652; DYNDH1228, Lot Number 23DBK822; DYNDH1540A, Lot Number 2023091990; DYNDH1827, Lot Number 24BMB809; DYNDH1932, Lot Number 2023121180; DYNDL1462B, Lot Number 2019012450; DYNJ0105963Q, Lot Number 22GMH630; DYNJ0105963Q, Lot Number 22EMG581; DYNJ0105963Q, Lot Number 22CMI727; DYNJ0105963Q, Lot Number 22CMA702; DYNJ0161912G, Lot Number 23KDB964; DYNJ0173400P, Lot Number 21FMC951; DYNJ0173400P, Lot Number 21DME907; DYNJ0173400P, Lot Number 21CMB877; DYNJ0173400P, Lot Number 21AMB468; DYNJ0173400P, Lot Number 20LME686; DYNJ0173400P, Lot Number 20LMC387; DYNJ0173400P, Lot Number 20JMC557; DYNJ0173400P, Lot Number 20IMB398; DYNJ0173400P, Lot Number 20GMC663; DYNJ0173400P, Lot Number 20EMA806; DYNJ0173400P, Lot Number 20EMA459; DYNJ0173400P, Lot Number 20BBR274; DYNJ0194968AG, Lot Number 24CMC638; DYNJ0194968AG, Lot Number 24BME100; DYNJ0275614F, Lot Number 24CMD821; DYNJ0275614F, Lot Number 24AMJ414; DYNJ0429201L, Lot Number 24BMI261; DYNJ04386U, Lot Number 24CMF538; DYNJ04562S, Lot Number 23BLA247; DYNJ04562S, Lot Number 23ALA434; DYNJ04562S, Lot Number 23ALA227; DYNJ04562S, Lot Number 22KLA758; DYNJ04562S, Lot Number 22KLA141; DYNJ04562S, Lot Number 22JLA659; DYNJ04562S, Lot Number 22ILA617; DYNJ04562S, Lot Number 22GLA997; DYNJ04674U, Lot Number 24BMJ236; DYNJ04674U, Lot Number 24BMB067; DYNJ04674UH, Lot Number 24BMJ236; DYNJ04674UH, Lot Number 24BMB067; DYNJ04674UH, Lot Number 23DMF209 ; DYNJ04674UH, Lot Number 23EMJ411 ; DYNJ04674UH, Lot Number 23FMD591 ; DYNJ04674UH, Lot Number 24AMB874 ; DYNJ0490280PH, Lot Number 21HMD962 ; DYNJ0490280PH, Lot Number 21JMH929 ; DYNJ0490280PH, Lot Number 19AKC431 ; DYNJ0490280PH, Lot Number 21KME862 ; DYNJ0490280PH, Lot Number 19BKB887 ; DYNJ0490280PH, Lot Number 19DKA387 ; DYNJ0490280PH, Lot Number 22AMB750 ; DYNJ0490280PH, Lot Number 22BMB089 ; DYNJ0490280PH, Lot Number 22CMF731 ; DYNJ0490280PH, Lot Number 22DME928 ; DYNJ0490280PH, Lot Number 22FMG329 ; DYNJ0490280PH, Lot Number 22HMG030 ; DYNJ0490280PH, Lot Number 22JMC980 ; DYNJ0490280PH, Lot Number 22LME104 ; DYNJ0490280PH, Lot Number 23AMB149 ; DYNJ0490280PH, Lot Number 23BMH102 ; DYNJ0490280PH, Lot Number 23EMG454 ; DYNJ0490280PH, Lot Number 23FMF799 ; DYNJ0490280PH, Lot Number 23GMD123 ; DYNJ0490280PH, Lot Number 23HMI667 ; DYNJ0490280PH, Lot Number 23JMA312 ; DYNJ0490280PH, Lot Number 23JMJ462 ; DYNJ0490280PH, Lot Number 24AMC475 ; DYNJ0537652AG, Lot Number 24BMB728; DYNJ0621195TH, Lot Number 21CMC148 ; DYNJ0621195TH, Lot Number 21DMA294 ; DYNJ0621195TH, Lot Number 21FMA079 ; DYNJ0621195TH, Lot Number 21GMD642 ; DYNJ0621195TH, Lot Number 19AKA773 ; DYNJ0621195TH, Lot Number 19CKA323 ; DYNJ0621195TH, Lot Number 21LMC489 ; DYNJ0621195TH, Lot Number 19DKC783 ; DYNJ0621195TH, Lot Number 21LMG876 ; DYNJ0621195TH, Lot Number 19GKB265 ; DYNJ0621195TH, Lot Number 19HKB762 ; DYNJ0621195TH, Lot Number 19IKC226 ; DYNJ0621195TH, Lot Number 19KKC114 ; DYNJ0621195TH, Lot Number 22CMB662 ; DYNJ0621195TH, Lot Number 22DME047 ; DYNJ0621195TH, Lot Number 22EMG769 ; DYNJ0621195TH, Lot Number 22EMG770 ; DYNJ0621195TH, Lot Number 22GMD234 ; DYNJ0621195TH, Lot Number 22HMF623 ; DYNJ0621195TH, Lot Number 22HMF626 ; DYNJ0621195TH, Lot Number 22HMF805 ; DYNJ0621195TH, Lot Number 22KMH017 ; DYNJ0621195TH, Lot Number 22LMH919 ; DYNJ0621195TH, Lot Number 23BMH224 ; DYNJ0621195TH, Lot Number 23DMC659 ; DYNJ0621195TH, Lot Number 23EMH238 ; DYNJ0621195TH, Lot Number 23FMF954 ; DYNJ0621195TH, Lot Number 23GME622 ; DYNJ0621195TH, Lot Number 23HMD011 ; DYNJ0621195TH, Lot Number 23IMH238 ; DYNJ0621195TH, Lot Number 23KME312 ; DYNJ0621195TH, Lot Number 23KMF280 ; DYNJ0621195TH, Lot Number 23KMF847 ; DYNJ0621195TH, Lot Number 23KMG596 ; DYNJ0621195TH, Lot Number 23LMH452 ; DYNJ0755738R, Lot Number 24BMC278; DYNJ0781476AAH , Lot Number 22EME967 ; DYNJ0781476AAH , Lot Number 22FMG782 ; DYNJ0781476AAH , Lot Number 22FMG783 ; DYNJ0781476AAH , Lot Number 22HMH711 ; DYNJ0781476AAH , Lot Number 23GMC354 ; DYNJ0781476AAH , Lot Number 23JMF525 ; DYNJ0781476AAH , Lot Number 23KMA657 ; DYNJ0781476AAH , Lot Number 23KME613 ; DYNJ0781476AAH , Lot Number 23KMJ481 ; DYNJ0781476AAH , Lot Number 24AMA131 ; DYNJ0781476AAH , Lot Number 24BMF082 ; DYNJ0781476AAH , Lot Number 24CMA858 ; DYNJ0781918NH, Lot Number 19LMA158 ; DYNJ07919GH, Lot Number 21GBB755 ; DYNJ07919GH, Lot Number 21HBU581 ; DYNJ07919GH, Lot Number 21JBZ187 ; DYNJ07919GH, Lot Number 21WBA117 ; DYNJ07919GH, Lot Number 21WBA928 ; DYNJ07919GH, Lot Number 21LBW658 ; DYNJ07919GH, Lot Number 22ABG228 ; DYNJ07919GH, Lot Number 22ABW646 ; DYNJ07919GH, Lot Number 19ABD174 ; DYNJ07919GH, Lot Number 19BBI258 ; DYNJ07919GH, Lot Number 19CBD215 ; DYNJ07919GH, Lot Number 22OBJ080 ; DYNJ07919GH, Lot Number 22DBN531 ; DYNJ07919GH, Lot Number 19DBK522 ; DYNJ07919GH, Lot Number 22EBN350 ; DYNJ07919GH, Lot Number 19EBA372 ; DYNJ07919GH, Lot Number 22GBJ853 ; DYNJ07919GH, Lot Number 19FBK929 ; DYNJ07919GH, Lot Number 19GBW574 ; DYNJ07919GH, Lot Number 22IBK744 ; DYNJ07919GH, Lot Number 19HBE646 ; DYNJ07919GH, Lot Number 19HBM345 ; DYNJ07919GH, Lot Number 22JBD628 ; DYNJ07919GH, Lot Number 22KBF159 ; DYNJ07919GH, Lot Number 19JBI461 ; DYNJ07919GH, Lot Number 23ABK220 ; DYNJ07919GH, Lot Number 19KBU453 ; DYNJ07919GH, Lot Number 23CBM139 ; DYNJ07919GH, Lot Number 23CBV596 ; DYNJ07919GH, Lot Number 23DBO846 ; DYNJ07919GH, Lot Number 23EBS913 ; DYNJ07919GH, Lot Number 23FBJ315 ; DYNJ07919GH, Lot Number 23HBJ763 ; DYNJ07919GH, Lot Number 23IBG534 ; DYNJ07919GH, Lot Number 23JBP625 ; DYNJ07919GH, Lot Number 23KBV909 ; DYNJ07919GH, Lot Number 24ABA869 ; DYNJ07919GH, Lot Number 21ABT102 ; DYNJ07919GH, Lot Number 21BBF501 ; DYNJ0830939ACH , Lot Number 23KME948 ; DYNJ0830939ACH , Lot Number 23LMH653 ; DYNJ0843627G , Lot Number 19JDA113 ; DYNJ0843627G , Lot Number 19LDA741 ; DYNJ0843627G , Lot Number 20ADD013 ; DYNJ0843627G , Lot Number 20CDB405 ; DYNJ0843627G , Lot Number 20EDA304 ; DYNJ0843627G , Lot Number 20FDB013 ; DYNJ0843627G , Lot Number 20HDA724 ; DYNJ0843627G , Lot Number 20KDC483 ; DYNJ0843627G , Lot Number 21ADB521 ; DYNJ0843627G , Lot Number 21BDB149 ; DYNJ0843627G , Lot Number 21DDA579 ; DYNJ0843627G , Lot Number 21EDB315 ; DYNJ0880659D, Lot Number 21JBZ445; DYNJ0880659D, Lot Number 21JBZ448; DYNJ0880659D, Lot Number 21IBG203; 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DYNJ54704FH, Lot Number 22KBD295 ; DYNJ54704FH, Lot Number 23ABQ511 ; DYNJ54704FH, Lot Number 23BBD735 ; DYNJ54704FH, Lot Number 23DBI843 ; DYNJ54704FH, Lot Number 23EBL306 ; DYNJ54704FH, Lot Number 23FBB640 ; DYNJ54704FH, Lot Number 23GBL713 ; DYNJ54704FH, Lot Number 23IBU922 ; DYNJ54704FH, Lot Number 23JBU316 ; DYNJ54759H , Lot Number 21KBQ998 ; DYNJ54759H , Lot Number 22BBT936 ; DYNJ54759H , Lot Number 22OBA976 ; DYNJ54759H , Lot Number 19CBS587 ; DYNJ54759H , Lot Number 19TBD937 ; DYNJ54759H , Lot Number 22LBR919 ; DYNJ54759H , Lot Number 23ABJ140 ; DYNJ54759H , Lot Number 19KBG955 ; DYNJ54759H , Lot Number 19LBU424 ; DYNJ54759H , Lot Number 23DBB536 ; DYNJ54759H , Lot Number 23FBN119 ; DYNJ54759H , Lot Number 23HBC296 ; DYNJ54759H , Lot Number 20DBP692 ; DYNJ54759H , Lot Number 20EBQ535 ; DYNJ54759H , Lot Number 20GBS306 ; DYNJ54759H , Lot Number 20HBL697 ; DYNJ54759H , Lot Number 20IBS035 ; DYNJ54759H , Lot Number 20LBM637 ; DYNJ55352A, Lot Number 23KBN830; DYNJ55352A, Lot Number 23JBO433; DYNJ55352A, Lot Number 23HBK208; DYNJ55352A, Lot Number 23GBI660; DYNJ55352A, Lot Number 23FBK324; DYNJ55352A, Lot Number 23EBF584; DYNJ55352A, Lot Number 23CBN279; DYNJ55352A, Lot Number 22LBE925; DYNJ55352A, Lot Number 22LBB760; DYNJ55352A, Lot Number 22KBH188; DYNJ55352A, Lot Number 22JBL274; DYNJ55352A, Lot Number 22IBC941; DYNJ55352A, Lot Number 22HBL854; DYNJ55352A, Lot Number 22GBH824; DYNJ55352A, Lot Number 22FBL491; DYNJ55352A, Lot Number 22EBH563; DYNJ55352A, Lot Number 22BBW822; DYNJ55352A, Lot Number 22MBA245; DYNJ55352A, Lot Number 21LBT347; DYNJ55352A, Lot Number 21VBB834; DYNJ55352A, Lot Number 21HBQ697; DYNJ55352A, Lot Number 21DBS097; DYNJ55352A, Lot Number 21BBM970; DYNJ55352A, Lot Number 20LBS769; DYNJ55352A, Lot Number 20JBL438; DYNJ55352A, Lot Number 20GBA541; DYNJ55352A, Lot Number 20BBK164; DYNJ55352A, Lot Number 20ABZ125; DYNJ56255B, Lot Number 24BLA925; DYNJ56378G, Lot Number 24CMC598; DYNJ56378G, Lot Number 24BMA499; DYNJ57685BH, Lot Number 21HMG832 ; DYNJ57685BH, Lot Number 22AMC145 ; DYNJ57685BH, Lot Number 22CMJ126 ; DYNJ57685BH, Lot Number 22EMA550 ; DYNJ57685BH, Lot Number 22FMA863 ; DYNJ57685BH, Lot Number 22GME902 ; DYNJ57685BH, Lot Number 22HMC011 ; DYNJ57685BH, Lot Number 22HMI037 ; DYNJ57685BH, Lot Number 22KMH699 ; DYNJ57685BH, Lot Number 23BMD485 ; DYNJ57685BH, Lot Number 23EMB679 ; DYNJ57685BH, Lot Number 23EMK046 ; DYNJ57685BH, Lot Number 23FMI778 ; DYNJ57685BH, Lot Number 23GME136 ; DYNJ57685BH, Lot Number 23IMD282 ; DYNJ57685BH, Lot Number 23JMA052 ; DYNJ57685BH, Lot Number 23JMC428 ; DYNJ57685BH, Lot Number 23LME792 ; DYNJ57685BH, Lot Number 24BMH831 ; DYNJ57723C, Lot Number 24BMD176; DYNJ59893BH, Lot Number 21KBW276 ; DYNJ59893BH, Lot Number 22BBJ057 ; DYNJ59893BH, Lot Number 22NBB317 ; DYNJ59893BH, Lot Number 22NBB319 ; DYNJ59893BH, Lot Number 22EBH526 ; DYNJ59893BH, Lot Number 22HBH440 ; DYNJ59893BH, Lot Number 22HBM205 ; DYNJ59893BH, Lot Number 22JBS681 ; DYNJ59893BH, Lot Number 22KBH312 ; DYNJ59893BH, Lot Number 22LBB108 ; DYNJ59893BH, Lot Number 23GBD440 ; DYNJ59893BH, Lot Number 23GBS355 ; DYNJ59893BH, Lot Number 23KBA502 ; DYNJ59893BH, Lot Number 23KBW947 ; DYNJ59893BH, Lot Number 23LBS294 ; DYNJ59898BH, Lot Number 21KBN438 ; DYNJ59898BH, Lot Number 21LBF430 ; DYNJ59898BH, Lot Number 22BBB648 ; DYNJ59898BH, Lot Number 22CBC054 ; DYNJ59898BH, Lot Number 22DBM996 ; DYNJ59898BH, Lot Number 22EBR846 ; DYNJ59898BH, Lot Number 22GBM877 ; DYNJ59898BH, Lot Number 22HBR328 ; DYNJ59898BH, Lot Number 22JBN705 ; DYNJ59898BH, Lot Number 22JBQ762 ; DYNJ59898BH, Lot Number 22LBE131 ; DYNJ59898BH, Lot Number 23ABR592 ; DYNJ59898BH, Lot Number 23BBO064 ; DYNJ59898BH, Lot Number 23DBM515 ; DYNJ59898BH, Lot Number 23EBQ916 ; DYNJ59898BH, Lot Number 23FBS147 ; DYNJ59898BH, Lot Number 23GBL692 ; DYNJ59898BH, Lot Number 23HBP704 ; DYNJ59898BH, Lot Number 23JBN221 ; DYNJ59898BH, Lot Number 23KBS374 ; DYNJ59931BH, Lot Number 22BBX590 ; DYNJ59931BH, Lot Number 22DBM388 ; DYNJ59931BH, Lot Number 22DBS611 ; DYNJ59931BH, Lot Number 22FBU003 ; DYNJ59931BH, Lot Number 22HBI355 ; DYNJ59931BH, Lot Number 22KBH299 ; DYNJ59931BH, Lot Number 22LBA917 ; DYNJ59931BH, Lot Number 23ABL095 ; DYNJ59931BH, Lot Number 23CBU118 ; DYNJ59931BH, Lot Number 23EBN753 ; DYNJ59931BH, Lot Number 23GBC772 ; DYNJ59931BH, Lot Number 23JBO886 ; DYNJ59931BH, Lot Number 23KBP469 ; DYNJ59931BH, Lot Number 23KBT133 ; DYNJ59931BH, Lot Number 23LBP220 ; DYNJ60112B, Lot Number 24BMG407; DYNJ60405C, Lot Number 24CMB841; DYNJ60405C, Lot Number 24BMC988; DYNJ60424A, Lot Number 24BMC104; DYNJ60533C, Lot Number 24CMB458; DYNJ60533C, Lot Number 24BMC106; DYNJ60533C, Lot Number 24CMB458; DYNJ60533C, Lot Number 24BMC106; DYNJ60655D, Lot Number 24BMG238; DYNJ60655D, Lot Number 24BMA787; DYNJ62086F, Lot Number 24BMI705; DYNJ62086F, Lot Number 24BMI705; DYNJ62609DH, Lot Number 22JLA172 ; DYNJ62609DH, Lot Number 22KLA005 ; DYNJ62609DH, Lot Number 23ALA693 ; DYNJ62609DH, Lot Number 23LLA772 ; DYNJ62609DH, Lot Number 24ALA003 ; DYNJ62609DH, Lot Number 24ALB059 ; DYNJ62980A, Lot Number 24AMB177; DYNJ62980A, Lot Number 23IMH731; DYNJ62980A, Lot Number 23IMC714; DYNJ62980A, Lot Number 23IMA210; DYNJ62980A, Lot Number 23HMH070; DYNJ62980A, Lot Number 23GMI101; DYNJ62980A, Lot Number 23GMB319; DYNJ62980A, Lot Number 23FMI809; DYNJ62980A, Lot Number 23EMC205; DYNJ62980A, Lot Number 23DME222; DYNJ62980A, Lot Number 23BMD380; DYNJ62980A, Lot Number 22LMF630; DYNJ62980A, Lot Number 22JMB790; DYNJ62980A, Lot Number 22IMC933; DYNJ62980A, Lot Number 22HMB197; DYNJ62980A, Lot Number 22EMH686; DYNJ62980A, Lot Number 22EMA467; DYNJ62980A, Lot Number 22CMJ137; DYNJ63686C, Lot Number 23JBP460; DYNJ64525BH, Lot Number 21JBR200 ; DYNJ64525BH, Lot Number 21KBM325 ; DYNJ64525BH, Lot Number 21LBJ452 ; DYNJ64525BH, Lot Number 22BBS908 ; DYNJ64525BH, Lot Number 22NBE425 ; DYNJ64525BH, Lot Number 22CBZ142 ; DYNJ64525BH, Lot Number 22EBH209 ; DYNJ64525BH, Lot Number 22GBT896 ; DYNJ64525BH, Lot Number 23BBD176 ; DYNJ64525BH, Lot Number 23BBO100 ; DYNJ64525BH, Lot Number 23EBJ205 ; DYNJ64525BH, Lot Number 23EBW847 ; DYNJ64525BH, Lot Number 23FBR366 ; DYNJ64525BH, Lot Number 23GBK785 ; DYNJ64525BH, Lot Number 23GBT353 ; DYNJ64525BH, Lot Number 23HBK725 ; DYNJ64525BH, Lot Number 23IBE961 ; DYNJ64525BH, Lot Number 23JBG437 ; DYNJ64525BH, Lot Number 23LBA330 ; DYNJ64546BH, Lot Number 21IBL728 ; DYNJ64546BH, Lot Number 21KBP107 ; DYNJ64546BH, Lot Number 23EBC124 ; DYNJ64546BH, Lot Number 23JBD109 ; DYNJ64548DH, Lot Number 23HBC766 ; DYNJ64548DH, Lot Number 23HBI072 ; DYNJ64587AH, Lot Number 22BBY939 ; DYNJ64587AH, Lot Number 22CBU206 ; DYNJ64587AH, Lot Number 22OBK428 ; DYNJ64587AH, Lot Number 22EBL781 ; DYNJ64587AH, Lot Number 22EBL782 ; DYNJ64587AH, Lot Number 22KBV934 ; DYNJ64587AH, Lot Number 23ABN267 ; DYNJ64587AH, Lot Number 23ABS667 ; DYNJ64587AH, Lot Number 23CBK426 ; DYNJ64587AH, Lot Number 23DBJ436 ; DYNJ64587AH, Lot Number 23EBI108 ; DYNJ64587AH, Lot Number 23FBH225 ; DYNJ64587AH, Lot Number 23GBB016 ; DYNJ64587AH, Lot Number 23HBB670 ; DYNJ64587AH, Lot Number 23JBA945 ; DYNJ64587AH, Lot Number 23JBM612 ; DYNJ64587AH, Lot Number 23KBL706 ; DYNJ64587AH, Lot Number 23LBT821 ; DYNJ64620H , Lot Number 21IBD120 ; DYNJ64620H , Lot Number 21JBC520 ; DYNJ64620H , Lot Number 21KBC208 ; DYNJ64620H , Lot Number 21LBG582 ; DYNJ64620H , Lot Number 22ABA558 ; DYNJ64620H , Lot Number 22CBA435 ; DYNJ64620H , Lot Number 22OBE449 ; DYNJ64620H , Lot Number 22DBU504 ; DYNJ64620H , Lot Number 22FBJ147 ; DYNJ64620H , Lot Number 22GBE449 ; DYNJ64620H , Lot Number 22IBK125 ; DYNJ64620H , Lot Number 22IBP210 ; DYNJ64620H , Lot Number 22KBE166 ; DYNJ64620H , Lot Number 22LBK893 ; DYNJ64620H , Lot Number 23ABJ191 ; DYNJ64620H , Lot Number 23BBQ870 ; DYNJ64620H , Lot Number 23EBA313 ; DYNJ64620H , Lot Number 23FBO928 ; DYNJ64620H , Lot Number 23GBL683 ; DYNJ64620H , Lot Number 23GBR414 ; DYNJ64620H , Lot Number 23JBM176 ; DYNJ64620H , Lot Number 23KBC219 ; DYNJ64620H , Lot Number 23LBB152 ; DYNJ64626BH, Lot Number 22HBF983 ; DYNJ64626BH, Lot Number 22HBO590 ; DYNJ64626BH, Lot Number 22IBJ761 ; DYNJ64626BH, Lot Number 22JBG356 ; DYNJ64626BH, Lot Number 22KBS705 ; DYNJ64626BH, Lot Number 22LBO971 ; DYNJ64626BH, Lot Number 23ABN271 ; DYNJ64626BH, Lot Number 23EBF819 ; DYNJ64626BH, Lot Number 23FBU846 ; DYNJ64626BH, Lot Number 23GBO963 ; DYNJ64626BH, Lot Number 23IBR519 ; DYNJ64626BH, Lot Number 23JBL760 ; DYNJ64626BH, Lot Number 23LBG554 ; DYNJ64936BH, Lot Number 22HBY850 ; DYNJ64936BH, Lot Number 22LBQ523 ; DYNJ64936BH, Lot Number 23ABK408 ; DYNJ64936BH, Lot Number 23BBP118 ; DYNJ64936BH, Lot Number 23DBP201 ; DYNJ64936BH, Lot Number 23EBI424 ; DYNJ64936BH, Lot Number 23FBF158 ; DYNJ64936BH, Lot Number 23GBM124 ; DYNJ64936BH, Lot Number 23HBW852 ; DYNJ64936BH, Lot Number 23JBA954 ; DYNJ64936BH, Lot Number 23KBI356 ; DYNJ64990B, Lot Number 24BMD874; DYNJ65162BH, Lot Number 23HBD541 ; DYNJ65162BH, Lot Number 23IBC495 ; DYNJ65162BH, Lot Number 23JBU189 ; DYNJ65162BH, Lot Number 23KBA866 ; DYNJ65162BH, Lot Number 23LBL832 ; DYNJ65162BH, Lot Number 23LBT273 ; DYNJ65238B, Lot Number 23GMB562; DYNJ65238B, Lot Number 22HMH793; DYNJ65238B, Lot Number 22FMI017; DYNJ65238B, Lot Number 22EMF834; DYNJ65238B, Lot Number 22BMG103; DYNJ65481, Lot Number 24BMJ722; DYNJ65481, Lot Number 24BMF056; DYNJ65578A, Lot Number 24BMJ184;

Distribution pattern

Worldwide distribution.

device · product 14 of 81

Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH

Z-2994-2024
Recall number
Z-2994-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYKMBNDL37AH, Lot Number 22IBB075

Distribution pattern

Worldwide distribution.

device · product 15 of 81

Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ; 6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ; 7) LEFT HEART TRAY , Pack Number 00-401880I ; 8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ; 9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ; 10) ADVANTEC-MLD, Pack Number 00-500510D ; 11) ADVANTEC-MLD, Pack Number 00-500510F ; 12) KIT ANGIO CSTM-WALKER, Pack Number 129969; 13) DIAGNOSTIC KIT, Pack Number 147943; 14) MSC - CRESCENT MEDICAL, Pack Number 149155; 15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111; 16) OPEN HEART CDS, Pack Number CDS840015AK; 17) OPEN HEART CDS, Pack Number CDS840015AL; 18) OPEN HEART CDS, Pack Number CDS840015AM; 19) OPEN HEART CDS, Pack Number CDS840015AN; 20) OPEN HEART CDS, Pack Number CDS840015AO; 21) OPEN HEART CDS, Pack Number CDS840015AP; 22) OPEN HEART CDS, Pack Number CDS840015AQ; 23) OPEN HEART CDS, Pack Number CDS840015AQ; 24) OPEN HEART CDS, Pack Number CDS840016AD; 25) OPEN HEART CDS, Pack Number CDS840016AD; 26) OPEN HEART CDS, Pack Number CDS840023R ; 27) OPEN HEART CDS, Pack Number CDS840023S ; 28) OPEN HEART CDS, Pack Number CDS840023T ; 29) AAA CDS , Pack Number CDS840076AC; 30) OFF PUMP CABG CDS , Pack Number CDS840087AB; 31) OFF PUMP CABG CDS , Pack Number CDS840087AD; 32) OFF PUMP CABG CDS , Pack Number CDS840087AF; 33) OFF PUMP CABG CDS , Pack Number CDS840087AG; 34) OFF PUMP CABG CDS , Pack Number CDS840087AI; 35) OFF PUMP CABG CDS , Pack Number CDS840087AJ; 36) OFF PUMP CABG CDS , Pack Number CDS840087AK; 37) OFF PUMP CABG CDS , Pack Number CDS840087AL; 38) OPEN HEART CDS, Pack Number CDS840094L ; 39) OPEN HEART CDS, Pack Number CDS840094M ; 40) OPEN HEART CDS, Pack Number CDS840094N ; 41) OPEN HEART CDS, Pack Number CDS840094P ; 42) OPEN HEART CDS, Pack Number CDS840108J ; 43) OPEN HEART CDS, Pack Number CDS840108K ; 44) OPEN HEART CDS, Pack Number CDS840132N ; 45) OPEN HEART CDS, Pack Number CDS840132O ; 46) OPEN HEART CDS, Pack Number CDS840144O ; 47) OPEN HEART CDS, Pack Number CDS840144P ; 48) OPEN HEART CDS, Pack Number CDS840144Q ; 49) OPEN HEART CDS, Pack Number CDS840144Q ; 50) OPEN HEART CDS, Pack Number CDS840145S ; 51) OPEN HEART CDS, Pack Number CDS840145T ; 52) OPEN HEART CDS, Pack Number CDS840145U ; 53) OPEN HEART, Pack Number CDS840150R ; 54) OPEN HEART, Pack Number CDS840150S ; 55) OPEN HEART, Pack Number CDS840150T ; 56) OPEN HEART, Pack Number CDS840150U ; 57) OPEN HEART, Pack Number CDS840150V ; 58) PACEMAKER CDS , Pack Number CDS840162S ; 59) PACEMAKER CDS , Pack Number CDS840162T ; 60) PACEMAKER CDS , Pack Number CDS840162U ; 61) PACEMAKER CDS , Pack Number CDS840162V ; 62) OPEN HEART CDS, Pack Number CDS840171AA; 63) OPEN HEART CDS, Pack Number CDS840171AB; 64) OPEN HEART CDS, Pack Number CDS840171AC; 65) OPEN HEART CDS, Pack Number CDS840171AD; 66) HEART CDS , Pack Number CDS840179M ; 67) HEART CDS, Pack Number CDS840179M ; 68) MINOR VASCULAR PACK , Pack Number CDS840184M ; 69) MINOR VASCULAR PACK , Pack Number CDS840184N ; 70) MINOR VASCULAR PACK , Pack Number CDS840184O ; 71) MINOR VASCULAR PACK, Pack Number CDS840184P; 72) OPEN HEART PACK , Pack Number CDS840185S ; 73) OPEN HEART PACK , Pack Number CDS840185T ; 74) OPEN HEART PACK , Pack Number CDS840185U ; 75) OPEN HEART PACK , Pack Number CDS840185V ; 76) OPEN HEART PACK , Pack Number CDS840185W ; 77) VALVE PACK, Pack Number CDS840187S ; 78) VALVE PACK, Pack Number CDS840187T ; 79) OPEN HEART, Pack Number CDS840189R ; 80) MAJOR VASCULAR, Pack Number CDS840195T ; 81) MAJOR VASCULAR, Pack Number CDS840195U ; 82) CABG-LF , Pack Number CDS840231Q ; 83) CABG-LF , Pack Number CDS840231R ; 84) CABG-LF , Pack Number CDS840231S ; 85) CABG-LF , Pack Number CDS840231T ; 86) MAJOR VASCU

Z-2995-2024
Recall number
Z-2995-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

00-400361J , Lot Number 19GMA398 ; 00-400361J , Lot Number 19KMB977 ; 00-400361J , Lot Number 20AMB625 ; 00-400361J , Lot Number 20CMB790 ; 00-400361J , Lot Number 20EMB935 ; 00-400361J , Lot Number 20HMD638 ; 00-400361J , Lot Number 20JMF103 ; 00-400361J , Lot Number 20LMD909 ; 00-400361J , Lot Number 21HMA255 ; 00-400361J , Lot Number 21HMD608 ; 00-400361J , Lot Number 21JMG396 ; 00-400361J , Lot Number 21LMF121 ; 00-400361J , Lot Number 22AME293 ; 00-400361J , Lot Number 22BMF391 ; 00-400361J , Lot Number 22HMA827 ; 00-400361J , Lot Number 22LMA159 ; 00-400361J , Lot Number 23CMA918 ; 00-400361J , Lot Number 23EMG313 ; 00-400361J , Lot Number 23HME323 ; 00-400361J , Lot Number 19DKC989 ; 00-400361J , Lot Number 19EKD171 ; 00-401185Q , Lot Number 21BMC803 ; 00-401185Q , Lot Number 21CMB169 ; 00-401185Q , Lot Number 21FME996 ; 00-401185Q , Lot Number 21HMC811 ; 00-401185Q , Lot Number 21JMF649 ; 00-401185Q , Lot Number 22AMB298 ; 00-401185Q , Lot Number 22CMH907 ; 00-401185Q , Lot Number 22EMA951 ; 00-401185Q , Lot Number 22EME874 ; 00-401185Q , Lot Number 22FMF282 ; 00-401185Q , Lot Number 22FMF580 ; 00-401185Q , Lot Number 22HME725 ; 00-401185Q , Lot Number 22IMD217 ; 00-401185Q , Lot Number 22LMA438 ; 00-401185Q , Lot Number 23CMD526 ; 00-401185Q , Lot Number 23EMF518 ; 00-401185Q , Lot Number 23GMD389 ; 00-401185Q , Lot Number 23HMH421 ; 00-401185Q , Lot Number 23IMH814 ; 00-401521F , Lot Number 22CBE464 ; 00-401521F , Lot Number 19BBD936 ; 00-401521F , Lot Number 19EBL198 ; 00-401521F , Lot Number 19WBB570 ; 00-401521F , Lot Number 20EBD061 ; 00-401521F , Lot Number 20EBK193 ; 00-401521F , Lot Number 23JBT733 ; 00-401521F , Lot Number 20LBC052 ; 00-401521F , Lot Number 21ABI211 ; 00-401525G , Lot Number 21GBO675 ; 00-401525G , Lot Number 21IBA321 ; 00-401525G , Lot Number 21JBW514 ; 00-401525G , Lot Number 21LBP821 ; 00-401525G , Lot Number 22BBW574 ; 00-401525G , Lot Number 22CBZ322 ; 00-401525G , Lot Number 22OBD345 ; 00-401525G , Lot Number 19DBA953 ; 00-401525G , Lot Number 22EBS321 ; 00-401525G , Lot Number 19EBX278 ; 00-401525G , Lot Number 19EBX645 ; 00-401525G , Lot Number 19GBK251 ; 00-401525G , Lot Number 19SBD727 ; 00-401525G , Lot Number 22JBF078 ; 00-401525G , Lot Number 22KBQ242 ; 00-401525G , Lot Number 19VBD535 ; 00-401525G , Lot Number 19KBP818 ; 00-401525G , Lot Number 19LBD342 ; 00-401525G , Lot Number 23CBL714 ; 00-401525G , Lot Number 23EBI077 ; 00-401525G , Lot Number 23FBH811 ; 00-401525G , Lot Number 20DBC252 ; 00-401525G , Lot Number 23GBW352 ; 00-401525G , Lot Number 23IBB620 ; 00-401525G , Lot Number 20EBS479 ; 00-401525G , Lot Number 23JBH811 ; 00-401525G , Lot Number 20GBT714 ; 00-401525G , Lot Number 20JBC305 ; 00-401525G , Lot Number 21ABE171 ; 00-401525G , Lot Number 21CBS174 ; 00-401525G , Lot Number 21EBR135 ; 00-401561K , Lot Number 19ABB458 ; 00-401561K , Lot Number 19ABY023 ; 00-401561K , Lot Number 19CBB584 ; 00-401561K , Lot Number 19DBG969 ; 00-401561K , Lot Number 19EBG778 ; 00-401561K , Lot Number 19FBM963 ; 00-401561K , Lot Number 19SBG949 ; 00-401561K , Lot Number 19KBE358 ; 00-401594S , Lot Number 21EDA345 ; 00-401594S , Lot Number 21GDC290 ; 00-401594S , Lot Number 21HDC372 ; 00-401594S , Lot Number 21KDB536 ; 00-401594S , Lot Number 22BDA106 ; 00-401594S , Lot Number 22CDB669 ; 00-401594S , Lot Number 22CDC224 ; 00-401594S , Lot Number 22FDA001 ; 00-401594S , Lot Number 22GDA339 ; 00-401594S , Lot Number 22IDA127 ; 00-401594S , Lot Number 22JDC194 ; 00-401594S , Lot Number 23BDA244 ; 00-401594S , Lot Number 23BDB723 ; 00-401594S , Lot Number 23DDA900 ; 00-401594S , Lot Number 23FDB364 ; 00-401594S , Lot Number 23GDB492 ; 00-401594S , Lot Number 23JDA045 ; 00-401594S , Lot Number 23LDC052 ; 00-401594S , Lot Number 24BDA515 ; 00-401880I , Lot Number 21FBR920 ; 00-401880I , Lot Number 21IBN364 ; 00-401880I , Lot Number 21KBJ427 ; 00-401880I , Lot Number 22ABH895 ; 00-401880I , Lot Number 22BBU351 ; 00-401880I , Lot Number 19ABO520 ; 00-401880I , Lot Number 19DBQ061 ; 00-401880I , Lot Number 22FBO924 ; 00-401880I , Lot Number 19FBM977 ; 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CDS840162S , Lot Number 19BBS629 ; CDS840162S , Lot Number 19CBL831 ; CDS840162T , Lot Number 19QBB393 ; CDS840162T , Lot Number 19HBH109 ; CDS840162T , Lot Number 19JBB891 ; CDS840162T , Lot Number 19KBY983 ; CDS840162T , Lot Number 20ABX239 ; CDS840162U , Lot Number 20CBW923 ; CDS840162U , Lot Number 20EBS141 ; CDS840162U , Lot Number 20GBI573 ; CDS840162U , Lot Number 20HBQ744 ; CDS840162U , Lot Number 20JBD177 ; CDS840162V , Lot Number 21HBK282 ; CDS840162V , Lot Number 21IBW787 ; CDS840162V , Lot Number 21KBY737 ; CDS840162V , Lot Number 21LBU087 ; CDS840162V , Lot Number 22BBV595 ; CDS840162V , Lot Number 22FBQ813 ; CDS840162V , Lot Number 22HBJ542 ; CDS840162V , Lot Number 22IBP339 ; CDS840162V , Lot Number 22KBG388 ; CDS840162V , Lot Number 23ABJ992 ; CDS840162V , Lot Number 23BBS863 ; CDS840162V , Lot Number 23DBD836 ; CDS840162V , Lot Number 23FBP694 ; CDS840162V , Lot Number 23HBU509 ; CDS840162V , Lot Number 23IBG251 ; CDS840162V , Lot Number 23KBF301 ; CDS840162V , Lot Number 23LBP266 ; CDS840162V , Lot Number 21DBC917 ; CDS840162V , Lot Number 21EBH228 ; CDS840171AA, Lot Number 21HBH678 ; CDS840171AA, Lot Number 21IBQ938 ; CDS840171AA, Lot Number 21IBX628 ; CDS840171AA, Lot Number 21JBP586 ; CDS840171AA, Lot Number 22ABW436 ; CDS840171AA, Lot Number 22BBQ794 ; CDS840171AA, Lot Number 22CMF202 ; CDS840171AA, Lot Number 22CMF807 ; CDS840171AA, Lot Number 22DMI794 ; CDS840171AB, Lot Number 22EMG542 ; CDS840171AB, Lot Number 22GMG011 ; CDS840171AB, Lot Number 22HMG560 ; CDS840171AC, Lot Number 22GMH076 ; CDS840171AC, Lot Number 22HMG266 ; CDS840171AC, Lot Number 22IMC485 ; CDS840171AC, Lot Number 22KMB419 ; CDS840171AC, Lot Number 22LMD442 ; CDS840171AC, Lot Number 23CMG687 ; CDS840171AD, Lot Number 23GMB956 ; CDS840171AD, Lot Number 23JMD203 ; CDS840171AD, Lot Number 23JME395 ; CDS840171AD, Lot Number 23JMF944 ; CDS840171AD, Lot Number 23KME173 ; CDS840179M , Lot Number 21GBU902 ; CDS840179M , Lot Number 21IBS492 ; CDS840179M , Lot Number 21IBV684 ; CDS840179M , Lot Number 22CBM613 ; CDS840179M , Lot Number 19BBQ377 ; CDS840179M , Lot Number 22CBU924 ; CDS840179M , Lot Number 19CBN962 ; CDS840179M , Lot Number 19DBS190 ; CDS840179M , Lot Number 22FBH408 ; CDS840179M , Lot Number 19EBW409 ; CDS840179M , Lot Number 19GBQ735 ; CDS840179M , Lot Number 22IBQ944 ; CDS840179M , Lot Number 22JBJ710 ; CDS840179M , Lot Number 19IBW710 ; CDS840179M , Lot Number 22KBT096 ; CDS840179M , Lot Number 22KBT202 ; CDS840179M , Lot Number 22KBT203 ; CDS840179M , Lot Number 23BBD729 ; CDS840179M , Lot Number 23DBT133 ; CDS840179M , Lot Number 23EBA474 ; CDS840179M , Lot Number 20BBW208 ; CDS840179M , Lot Number 23GBT785 ; CDS840179M , Lot Number 20DBM184 ; CDS840179M , Lot Number 23HBP976 ; CDS840179M , Lot Number 20EBV028 ; CDS840179M , Lot Number 23IBT068 ; CDS840179M , Lot Number 20HBC015 ; CDS840179M , Lot Number 23LBC741 ; CDS840179M , Lot Number 20IBQ927 ; CDS840179M , Lot Number 21ABW996 ; CDS840179M , Lot Number 21ABX529 ; CDS840179M , Lot Number 21DBA309 ; CDS840179M , Lot Number 21DBG113 ; CDS840179M , Lot Number 21EBO593 ; CDS840179M , Lot Number 24BBE226 ; CDS840184M , Lot Number 19CKD248 ; CDS840184N , Lot Number 19FKC134 ; CDS840184N , Lot Number 19GKB143 ; CDS840184N , Lot Number 19GKC784 ; CDS840184N , Lot Number 19HKA938 ; CDS840184N , Lot Number 19IKB128 ; CDS840184N , Lot Number 19JKC137 ; CDS840184N , Lot Number 20AKB908 ; CDS840184N , Lot Number 20CKA621 ; CDS840184N , Lot Number 20FKA899 ; CDS840184N , Lot Number 20GKA245 ; CDS840184N , Lot Number 20GKB061 ; CDS840184N , Lot Number 20HKA078 ; CDS840184N , Lot Number 20JKA815 ; CDS840184N , Lot Number 21AKB031 ; CDS840184O , Lot Number 21DME472 ; CDS840184O , Lot Number 21IMF705 ; CDS840184O , Lot Number 21JMI051 ; CDS840184O , Lot Number 21LMC275 ; CDS840184O , Lot Number 22CMH045 ; CDS840184O , Lot Number 22CMH045Z; CDS840184O , Lot Number 22FMC203 ; CDS840184O , Lot Number 22JMF329 ; CDS840184O , Lot Number 22JMG514 ; CDS840184O , Lot Number 23AME147 ; CDS840184O , Lot Number 23GMA425 ; CDS840184O , Lot Number 23HMB804 ; CDS840184O , Lot Number 21CKA224 ; CDS840184P, Lot Number 24CMG991; CDS840184P, Lot Number 24CMG438; CDS840184P , Lot Number 23KME149 ; CDS840185S , Lot Number 19AKB086 ; CDS840185S , Lot Number 19BKB841 ; CDS840185T , Lot Number 19DKA271 ; CDS840185T , Lot Number 19EKD810 ; CDS840185T , Lot Number 19HKB424 ; CDS840185T , Lot Number 19KKA620 ; CDS840185T , Lot Number 20AKA921 ; CDS840185T , Lot Number 20BKA408 ; CDS840185T , Lot Number 20BKA543 ; CDS840185T , Lot Number 20BKB164 ; CDS840185T , Lot Number 20CKA792 ; CDS840185T , Lot Number 20HKB818 ; CDS840185T , Lot Number 21CKA251 ; CDS840185U , Lot Number 21FMB007 ; CDS840185U , Lot Number 21FMB299 ; CDS840185U , Lot Number 21GMB134 ; CDS840185U , Lot Number 21GMC837 ; CDS840185U , Lot Number 21IMA908 ; CDS840185U , Lot Number 21KMA527 ; CDS840185V , Lot Number 22KMF107 ; CDS840185V , Lot Number 22LMG454 ; CDS840185V , Lot Number 23EMF369 ; CDS840185V , Lot Number 23KMI614 ; CDS840185W , Lot Number 24AMH833 ; CDS840185W , Lot Number 24BMB058 ; CDS840187S , Lot Number 19GKC791 ; CDS840187S , Lot Number 19JKB694 ; CDS840187S , Lot Number 19KKA197 ; CDS840187S , Lot Number 19LKA620 ; CDS840187S , Lot Number 20BKA557 ; CDS840187S , Lot Number 20DKA870 ; CDS840187S , Lot Number 20GKB141 ; CDS840187T , Lot Number 21FMB236 ; CDS840187T , Lot Number 21FME640 ; CDS840187T , Lot Number 21HMD893 ; CDS840187T , Lot Number 22AMF457 ; CDS840187T , Lot Number 22CMC917 ; CDS840187T , Lot Number 22FMG280 ; CDS840187T , Lot Number 22HMA002 ; CDS840187T , Lot Number 22IMD574 ; CDS840187T , Lot Number 22IMF709 ; CDS840187T , Lot Number 22JMG653 ; CDS840187T , Lot Number 22KMG318 ; CDS840187T , Lot Number 23DMH020 ; CDS840187T , Lot Number 23EMD178 ; CDS840187T , Lot Number 23FMD535 ; CDS840187T , Lot Number 23LMD524 ; CDS840187T , Lot Number 23LMH824 ; CDS840187T , Lot Number 24AMJ390 ; CDS840187T , Lot Number 21DKA491 ; CDS840189R , Lot Number 19BKA386 ; CDS840189R , Lot Number 19BKC818 ; CDS840189R , Lot Number 19CKB869 ; CDS840189R , Lot Number 19CKD146 ; CDS840195T , Lot Number 21FMB552 ; CDS840195T , Lot Number 21HMC403 ; CDS840195T , Lot Number 20EKA717 ; CDS840195T , Lot Number 21AKA081 ; CDS840195T , Lot Number 21BKA579 ; CDS840195T , Lot Number 21CKA227 ; CDS840195U , Lot Number 21JMB645 ; CDS840195U , Lot Number 21JME382 ; CDS840195U , Lot Number 21JMG165 ; CDS840195U , Lot Number 22DMG973 ; CDS840195U , Lot Number 23DMC061 ; CDS840195U , Lot Number 23EMD595 ; CDS840195U , Lot Number 23FMI496 ; CDS840195U , Lot Number 23HMD269 ; CDS840231Q , Lot Number 19ABW865 ; CDS840231Q , Lot Number 19CBM653 ; CDS840231Q , Lot Number 19PBB944 ; CDS840231Q , Lot Number 19QBA585 ; CDS840231Q , Lot Number 19GBJ910 ; CDS840231Q , Lot Number 19TBB330 ; CDS840231Q , Lot Number 19IBK311 ; CDS840231Q , Lot Number 19JBK940 ; CDS840231Q , Lot Number 19KBA016 ; CDS840231Q , Lot Number 20ABQ213 ; CDS840231Q , Lot Number 20BBJ966 ; CDS840231Q , Lot Number 20DBO098 ; CDS840231R , Lot Number 21GBW332 ; CDS840231R , Lot Number 21IBX701 ; CDS840231R , Lot Number 20EBS055 ; CDS840231R , Lot Number 20FBC956 ; CDS840231R , Lot Number 20GBJ875 ; CDS840231R , Lot Number 20IBR124 ; CDS840231R , Lot Number 20JBX637 ; CDS840231R , Lot Number 20KBS117 ; CDS840231R , Lot Number 21BBG045 ; CDS840231R , Lot Number 21CBG468 ; CDS840231R , Lot Number 21CBH403 ; CDS840231R , Lot Number 21CBR549 ; CDS840231R , Lot Number 21EBQ804 ; CDS840231R , Lot Number 21FBD643 ; CDS840231S , Lot Number 22ABS894 ; CDS840231S , Lot Number 22BBZ826 ; CDS840231S , Lot Number 22CBU922 ; CDS840231S , Lot Number 22EBI057 ; CDS840231S , Lot Number 22FBT378 ; CDS840231S , Lot Number 22IBT603 ; CDS840231S , Lot Number 22IBT892 ; CDS840231S , Lot Number 22LBB567 ; CDS840231S , Lot Number 22LBB568 ; CDS840231S , Lot Number 23ABQ332 ; CDS840231S , Lot Number 23CBP687 ; CDS840231S , Lot Number 23DBD693 ; CDS840231S , Lot Number 23EBG911 ; CDS840231S , Lot Number 23GBL901 ; CDS840231S , Lot Number 23GBN733 ; CDS840231S , Lot Number 23IBS026 ; CDS840231T , Lot Number 23LLA441 ; CDS840231T , Lot Number 24ALA060 ; CDS840231T , Lot Number 24ALA384 ; CDS840231T , Lot Number 24ALA796 ; CDS840231T , Lot Number 24CLA509 ; CDS840232K , Lot Number 21GBB798 ; CDS840232K , Lot Number 21GBQ453 ; CDS840232K , Lot Number 21HBO922 ; CDS840232K , Lot Number 20EBI686 ; CDS840232K , Lot Number 20GBH153 ; CDS840232K , Lot Number 20HBH802 ; CDS840232K , Lot Number 20IBS980 ; CDS840232K , Lot Number 20JBU645 ; CDS840232K , Lot Number 20JBX085 ; CDS840232K , Lot Number 20KBJ537 ; CDS840232K , Lot Number 20KBU777 ; CDS840232K , Lot Number 20LBF164 ; CDS840232K , Lot Number 21CBH405 ; CDS840232K , Lot Number 21DBP538 ; CDS840232L , Lot Number 21LBT071 ; CDS840232L , Lot Number 22ABD374 ; CDS840232L , Lot Number 22OBA532 ; CDS840232L , Lot Number 22OBM343 ; CDS840232L , Lot Number 22FBF374 ; CDS840232L , Lot Number 22FBX255 ; CDS840232L , Lot Number 22HBV242 ; CDS840232L , Lot Number 22IBA190 ; CDS840232L , Lot Number 22JBL420 ; CDS840232L , Lot Number 22LBQ596 ; CDS840232L , Lot Number 23ABQ980 ; CDS840232L , Lot Number 23CBW366 ; CDS840232L , Lot Number 23CBW387 ; CDS840232L , Lot Number 23EBQ492 ; CDS840232L , Lot Number 23IBS976 ; CDS840232M , Lot Number 23LBJ602 ; CDS840232M , Lot Number 24ABP181 ; CDS840233I , Lot Number 22ABN888 ; CDS840233I , Lot Number 22ABT326 ; CDS84023

Distribution pattern

Worldwide distribution.

device · product 16 of 81

Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number DYNDH1693A; 6) PACK,ULTRASOUND, Pack Number DYNDL1461; 7) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 8) ARTHROGRAM TRAY, Pack Number SPEC0143A; 9) PD CATH KIT, Pack Number UVT1205

Z-2996-2024
Recall number
Z-2996-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CVI4815, Lot Number 2022031150; CVI4815, Lot Number 2022042250; CVI4815, Lot Number 2022121390; CVI5045, Lot Number 2023101290; DYNDA2906, Lot Number 2022042250; DYNDH1319, Lot Number 2022031150; DYNDH1693A, Lot Number 2022042250; DYNDL1461, Lot Number 2022042250; DYNJTS4306, Lot Number 2022042250; SPEC0143A, Lot Number 2022042250; UVT1205, Lot Number 2022072650; UVT1205, Lot Number 2022081650

Distribution pattern

Worldwide distribution.

device · product 17 of 81

Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ; 6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ; 7) AV FISTULA PACK , Pack Number CDS840188M ; 8) VP SHUNT, Pack Number CDS840193V ; 9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ; 10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ; 11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH; 12) CENTRAL LINE CDS, Pack Number CDS930092V ; 13) CENTRAL LINE CDS, Pack Number CDS930092W ; 14) CENTRAL LINE CDS, Pack Number CDS930092X ; 15) C LINE INSERTION CDS, Pack Number CDS980379I ; 16) C LINE INSERTION CDS, Pack Number CDS980379J ; 17) AV FISTULA - SMH, Pack Number CDS980916L ; 18) AV FISTULA CDS, Pack Number CDS981513G ; 19) VASCULAR ACCESS CDS , Pack Number CDS981552F ; 20) VP SHUNT CDS, Pack Number CDS981740G ; 21) VP SHUNT CDS, Pack Number CDS981740I ; 22) PORT A CATH , Pack Number CDS982047Q ; 23) SHY VP SHUNT CDS, Pack Number CDS982389J; 24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ; 25) A-V FISTULA , Pack Number CDS982637K ; 26) A-V FISTULA , Pack Number CDS982637L ; 27) VASCULAR TRAUMA , Pack Number CDS982641K ; 28) AV FISTULA CDS, Pack Number CDS982660G ; 29) AV FISTULA CDS, Pack Number CDS982660I ; 30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ; 31) AV FISTULA/ACCESS , Pack Number CDS983060I ; 32) AV FISTULA/ACCESS , Pack Number CDS983060J ; 33) AV SHUNT CDS, Pack Number CDS983098B ; 34) AV SHUNT CDS, Pack Number CDS983098C ; 35) VASCULAR ACCESS CDS , Pack Number CDS983105C ; 36) VP SHUNT, Pack Number CDS983366K ; 37) VP SHUNT, Pack Number CDS983366L ; 38) AV FISTULA, Pack Number CDS983638G ; 39) AV FISTULA, Pack Number CDS983638I ; 40) AV FISTULA, Pack Number CDS983638J ; 41) BARIATRIC CDS , Pack Number CDS983657J ; 42) BARIATRIC CDS , Pack Number CDS983657K ; 43) BARIATRIC CDS , Pack Number CDS983883C ; 44) GROTH AV FISTULA CDS, Pack Number CDS984191P ; 45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ; 46) GROTH AV FISTULA CDS, Pack Number CDS984191S ; 47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ; 48) GROTH LASER VEIN, Pack Number CDS984193R; 49) SHY AV FISTULA CDS, Pack Number CDS984512G ; 50) AV FISTULA, Pack Number CDS985510G ; 51) THORACOSTOMY TRAY , Pack Number CHT2010; 52) TRAUMA CHEST TUBE SET , Pack Number CHT2015; 53) BARD MYPICC$ KIT, Pack Number CK000234A; 54) BARD MYPICC$ KIT, Pack Number CK000236A; 55) BARD MYPICC$ KIT, Pack Number CK000324 ; 56) BARD MYPICC$ KIT, Pack Number CK000325 ; 57) BARD MYPICC$ KIT, Pack Number CK000645A; 58) BARD MYPICC$ KIT, Pack Number CK000646A; 59) BARD MYPICC$ KIT, Pack Number CK000647A; 60) BARD MYPICC$ KIT, Pack Number CK000713 ; 61) BARD MYPICC$ KIT, Pack Number CK000714 ; 62) CENTRAL LINE TRAY , Pack Number CVI4705; 63) CVC INSERTION PACK, Pack Number CVI4720; 64) ****, Pack Number CVI4720B ; 65) KIT LINE INSERTION, Pack Number CVI4730; 66) KIT LINE INSERTION, Pack Number CVI4730A ; 67) VENOUS ACCESS TRAY, Pack Number CVI4830B ; 68) PORT INSERTION PACK , Pack Number CVI4870; 69) MVHS CVC LUMEN TRAY , Pack Number CVI4920; 70) NO CATHETER BUNDLE, Pack Number CVI4925A ; 71) UAMS PORT INSERTION KIT , Pack Number CVI5040; 72) CVL INSERTION PACK, Pack Number CVI5065; 73) CVL INSERTION PACK, Pack Number CVI5065H ; 74) HEMODIALYSIS TRAY , Pack Number DT8800 ; 75) ERCP KIT, Pack Number DYKE1006A; 76) PULMONARY KIT , Pack Number DYKE1870 ; 77) PULMONARY KIT, Pack Number DYKE1870H; 78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A; 79) ULTRASOUND PACK , Pack Number DYNDA1249A ; 80) CT SCAN-TC, Pack Number DYNDA1380A ; 81) CT SCAN-TC, Pack Number DYNDA1380AH; 82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077; 83) BAL KIT , Pack Number DYNDA2137B ; 84) STERILE PRE OP PACK , Pack Number

Z-2997-2024
Recall number
Z-2997-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

00-401649G , Lot Number 19IMB453 ; 00-401649G , Lot Number 19KMA787 ; 00-401649G , Lot Number 19LMC950 ; 00-401649G , Lot Number 20EMA317 ; 00-401649G , Lot Number 20EMC074 ; 00-401649G , Lot Number 20HMA234 ; 00-401649G , Lot Number 20JME695 ; 00-401649G , Lot Number 20LME609 ; 00-401649G , Lot Number 21BME658 ; 00-401649G , Lot Number 21CMB025 ; 00-401649G , Lot Number 21CMD185 ; 00-401649G , Lot Number 21DMA102 ; 00-401649G , Lot Number 21JMA649 ; 00-401649G , Lot Number 21JMF121 ; 00-401649G , Lot Number 19BKC121 ; 00-401649G , Lot Number 19CKD014 ; 00-401649G , Lot Number 19EKA045 ; 00-401649G , Lot Number 19GKA016 ; 00-401649G , Lot Number 19HKB535 ; 00-401649G , Lot Number 19IKB266 ; 00-401993O , Lot Number 23JBF090 ; 00-401993O , Lot Number 23KBH528 ; 00-401993O , Lot Number 23LBO811 ; 00-402001T , Lot Number 21GBL509 ; 00-402001T , Lot Number 21JBN647 ; 00-402001T , Lot Number 21JBZ697 ; 00-402001T , Lot Number 22BBX248 ; 00-402001T , Lot Number 22DBL467 ; 00-402001T , Lot Number 22DBS962 ; 00-402001T , Lot Number 22GBC939 ; 00-402001T , Lot Number 22HBO291 ; 00-402001T , Lot Number 22HBO322 ; 00-402001T , Lot Number 22IBN444 ; 00-402001T , Lot Number 22IBO023 ; 00-402001T , Lot Number 22KBT315 ; 00-402001T , Lot Number 23BBA151 ; 00-402001T , Lot Number 23CBI235 ; 00-402001T , Lot Number 23DBM140 ; 00-402001T , Lot Number 23EBT729 ; 00-402001T , Lot Number 23GBR995 ; 00-402001T , Lot Number 23GBS336 ; 00-402001U , Lot Number 23JBU819 ; 00-402001U , Lot Number 23LBG449 ; A134-MAX , Lot Number 19BKA379 ; A134-MAX , Lot Number 19DKB704 ; A134-MAX , Lot Number 19HKA891 ; A134-MAX , Lot Number 19KKA912 ; A134-MAX , Lot Number 19KKB286 ; A134-MAX , Lot Number 19KKB345 ; A134-MAX , Lot Number 20BKA796 ; A134-MAX , Lot Number 20EKA291 ; A134-MAX , Lot Number 20FKA121 ; A134-MAX , Lot Number 20FKB492 ; ARTNC175 , Lot Number 24AMF171 ; CDS840188M , Lot Number 21GME281 ; CDS840188M , Lot Number 21HMG887 ; CDS840188M , Lot Number 21LMG878 ; CDS840188M , Lot Number 22DMC877 ; CDS840188M , Lot Number 22FMF061 ; CDS840188M , Lot Number 22HMA885 ; CDS840188M , Lot Number 22HMG503 ; CDS840188M , Lot Number 22LMC521 ; CDS840188M , Lot Number 23JMC244 ; CDS840188M , Lot Number 23LMH857 ; CDS840188M , Lot Number 19DKC523 ; CDS840188M , Lot Number 19FKB927 ; CDS840188M , Lot Number 19GKC786 ; CDS840188M , Lot Number 19IKA428 ; CDS840188M , Lot Number 19LKB624 ; CDS840188M , Lot Number 20CKA278 ; CDS840188M , Lot Number 20EKB674 ; CDS840188M , Lot Number 20GKA668 ; CDS840188M , Lot Number 20IKA403 ; CDS840188M , Lot Number 20LKB098 ; CDS840188M , Lot Number 21CKA368 ; CDS840193V , Lot Number 21HBE520 ; CDS840193V , Lot Number 21HBE521 ; CDS840193V , Lot Number 21HBH244 ; CDS840193V , Lot Number 21JBE527 ; CDS840193V , Lot Number 21KBE066 ; CDS840193V , Lot Number 22ABM907 ; CDS840193V , Lot Number 22MBA145 ; CDS840193V , Lot Number 22DBP331 ; CDS840193V , Lot Number 22EBM213 ; CDS840193V , Lot Number 22EBN031 ; CDS840193V , Lot Number 22EBR456 ; CDS840193V , Lot Number 22GBU281 ; CDS840193V , Lot Number 23DBO524 ; CDS840193V , Lot Number 23EBW686 ; CDS840193V , Lot Number 23FBO564 ; CDS840193V , Lot Number 23IBQ501 ; CDS840193V , Lot Number 23JBD094 ; CDS840193V , Lot Number 23JBW804 ; CDS840193V , Lot Number 23JBX015 ; CDS840193V , Lot Number 21FBC630 ; CDS840295G , Lot Number 21FBN182 ; CDS840295G , Lot Number 21HBB477 ; CDS840295G , Lot Number 21HBB479 ; CDS840295G , Lot Number 21IBK120 ; CDS840295G , Lot Number 21JBU314 ; CDS840295G , Lot Number 21LBO663 ; CDS840295G , Lot Number 22OBI226 ; CDS840295G , Lot Number 22OBL670 ; CDS840295G , Lot Number 22GBA989 ; CDS840295G , Lot Number 22GBA991 ; CDS840295G , Lot Number 22GBA994 ; CDS840295G , Lot Number 19RBD411 ; CDS840295G , Lot Number 22HBQ573 ; CDS840295G , Lot Number 22IBE716 ; CDS840295G , Lot Number 19IBD862 ; CDS840295G , Lot Number 19IBJ104 ; CDS840295G , Lot Number 19VBC474 ; CDS840295G , Lot Number 19WBA922 ; CDS840295G , Lot Number 20ABS649 ; CDS840295G , Lot Number 20BBE304 ; CDS840295G , Lot Number 20BBZ155 ; CDS840295G , Lot Number 20EBG194 ; CDS840295G , Lot Number 20FBV524 ; CDS840295G , Lot Number 20HBC285 ; CDS840295G , Lot Number 20JBH402 ; CDS840295G , Lot Number 21BBA694 ; CDS840295G , Lot Number 21BBE943 ; CDS840295G , Lot Number 21BBG966 ; CDS840295G , Lot Number 21DBG123 ; CDS860033A , Lot Number 22ABT263 ; CDS860033A , Lot Number 22BBM414 ; CDS860033A , Lot Number 19ABO084 ; CDS860033A , Lot Number 19ABV178 ; CDS860033A , Lot Number 19BBD349 ; CDS860033A , Lot Number 19CBL856 ; CDS860033A , Lot Number 22DBN148 ; CDS860033A , Lot Number 19DBJ620 ; CDS860033A , Lot Number 22FBW038 ; CDS860033A , Lot Number 22GBT020 ; CDS860033A , Lot Number 19HBB212 ; CDS860033A , Lot Number 22JBI775 ; CDS860033A , Lot Number 19TBB915 ; CDS860033A , Lot Number 22KBO931 ; CDS860033A , Lot Number 19JBJ664 ; CDS860033A , Lot Number 23ABH649 ; CDS860033A , Lot Number 23BBH056 ; CDS860033A , Lot Number 20BBJ471 ; CDS860033A , Lot Number 20BBM839 ; CDS860033A , Lot Number 20CBA321 ; CDS860033A , Lot Number 23FBT671 ; CDS860033A , Lot Number 23GBT005 ; 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CVI5065, Lot Number 23LMH242 ; CVI5065H , Lot Number 23LMH242 ; DT8800 , Lot Number 23BBL592 ; DYKE1006A, Lot Number 23KMD664 ; DYKE1870 , Lot Number 23DLA914 ; DYKE1870 , Lot Number 23DLB045 ; DYKE1870 , Lot Number 23ELA392 ; DYKE1870 , Lot Number 23FLA252 ; DYKE1870 , Lot Number 23FLA911 ; DYKE1870 , Lot Number 23GLA888 ; DYKE1870H, Lot Number 23DLA914 ; DYKE1870H, Lot Number 23DLB045 ; DYKE1870H, Lot Number 23ELA392 ; DYKE1870H, Lot Number 23FLA252 ; DYKE1870H, Lot Number 23FLA911 ; DYKE1870H, Lot Number 23GLA888 ; DYKMBNDL43A, Lot Number 22IBK412 ; DYKMBNDL43A, Lot Number 22IBM493 ; DYKMBNDL43A, Lot Number 23ABK335 ; DYKMBNDL43A, Lot Number 23BBS866 ; DYNDA1249A , Lot Number 21JBT691 ; DYNDA1380A , Lot Number 21JBB707 ; DYNDA1380A , Lot Number 22DBK349 ; DYNDA1380A , Lot Number 22EBO224 ; DYNDA1380A , Lot Number 22IBA927 ; DYNDA1380A , Lot Number 22IBN710 ; DYNDA1380A , Lot Number 22LBH109 ; DYNDA1380A , Lot Number 23ABF213 ; DYNDA1380A , Lot Number 23EBM550 ; DYNDA1380A , Lot Number 23FBH621 ; DYNDA1380A , Lot Number 23GBC347 ; DYNDA1380A , Lot Number 23JBO772 ; DYNDA1380A , Lot Number 23KBQ517 ; DYNDA1380AH, Lot Number 21JBB707 ; DYNDA1380AH, Lot Number 22DBK349 ; DYNDA1380AH, Lot Number 22EBO224 ; DYNDA1380AH, Lot Number 22IBA927 ; DYNDA1380AH, Lot Number 22IBN710 ; DYNDA1380AH, Lot Number 22LBH109 ; DYNDA1380AH, Lot Number 23ABF213 ; DYNDA1380AH, Lot Number 23EBM550 ; DYNDA1380AH, Lot Number 23FBH621 ; DYNDA1380AH, Lot Number 23GBC347 ; DYNDA1380AH, Lot Number 23JBO772 ; DYNDA1380AH, Lot Number 23KBQ517 ; DYNDA2077, Lot Number 20IBP657; DYNDA2137B , Lot Number 23IBT323 ; DYNDA2654A , Lot Number 22JBM977 ; DYNDA2654A , Lot Number 22JBU450 ; DYNDA2654A , Lot Number 22LBN857 ; DYNDA2654B , Lot Number 22LBK150 ; DYNDA2654B , Lot Number 23BBD087 ; DYNDA2654B , Lot Number 23CBN996 ; DYNDA2654B , Lot Number 23FBM938 ; DYNDA2654B , Lot Number 23HBW413 ; DYNDA2654B , Lot Number 23IBS425 ; DYNDA2654B , Lot Number 23JBB731 ; DYNDA2736A , Lot Number 21JBR480 ; DYNDA2743, Lot Number 21GBD536 ; DYNDA2743, Lot Number 21IBR742 ; DYNDA2743, Lot Number 21JBR492 ; DYNDA2743, Lot Number 22ABC083 ; DYNDA2743, Lot Number 22DBG199 ; DYNDA2743, Lot Number 22IBT562 ; DYNDA2743, Lot Number 22LBQ221 ; DYNDA2743, Lot Number 23CBU790 ; DYNDA2743, Lot Number 23FBO269 ; DYNDA2743, Lot Number 23HBP847 ; DYNDA2743, Lot Number 23KBW261 ; DYNDA2743, Lot Number 20KBF866 ; DYNDA2743, Lot Number 20LBV309 ; DYNDA2743, Lot Number 21CBR854 ; DYNDA2743, Lot Number 21EBC647 ; DYNDA2743, Lot Number 21EBG462 ; DYNDA2759, Lot Number 22JBT428 ; DYNDA2759, Lot Number 22KBB523 ; DYNDA2759, Lot Number 22LBS589 ; DYNDA2759, Lot Number 23ABG086 ; DYNDA2759, Lot Number 21BBG643 ; DYNDA2759A , Lot Number 23GBQ402 ; DYNDA2759A , Lot Number 23GBT108 ; DYNDA2787A , Lot Number 23HBM205 ; DYNDA2787A , Lot Number 23JBV971 ; DYNDA2787A , Lot Number 23KBX493 ; DYNDA2990, Lot Number 22IBQ467 ; DYNDA2990, Lot Number 22KBN650 ; DYNDA2990, Lot Number 23EBK469 ; DYNDA2990, Lot Number 23EBQ567 ; DYNDA2990, Lot Number 23HBI808 ; DYNDA2990, Lot Number 23HBS300 ; DYNDA2990, Lot Number 23JBW267 ; DYNDA2990, Lot Number 23IMB381 ; DYNDA2998H , Lot Number 22KBB005 ; DYNDA2998H , Lot Number 23BBD525 ; DYNDA3007, Lot Number 23ABJ955 ; DYNDA3007, Lot Number 23CBN987 ; DYNDA3007, Lot Number 23DBR128 ; DYNDA3007, Lot Number 23EBP059 ; DYNDA3007, Lot Number 23IBL528 ; DYNDA3007, Lot Number 23JBY331 ; DYNDA3007, Lot Number 23LBP542 ; DYNDA3011AH, Lot Number 23JBG151 ; DYNDA3011AH, Lot Number 23KBT214 ; DYNDA3043, Lot Number 23FBR585 ; DYNDA3043, Lot Number 23JBJ847 ; DYNDA3043, Lot Number 23KBL940 ; DYNDA3112, Lot Number 24CMA077; DYNDC1110A , Lot Number 21JBV516 ; DYNDC1110AH, Lot Number 21JBV516 ; DYNDC1318F , Lot Number 23JBI259 ; DYNDC1960A, Lot Number 2018081350; DYNDC2057, Lot Number 23JBB732; DYNDC3129, Lot Number 21HBL665 ; DYNDC3251, Lot Number 22IBG587 ; DYNDC3251, Lot Number 22LBK717 ; DYNDC3251, Lot Number 23CBO992 ; DYNDC3251, Lot Number 23EBM260 ; DYNDC3251, Lot Number 23FBJ618 ; DYNDC3251, Lot Number 23GBW852 ; DYNDC3251, Lot Number 23HBU309 ; DYNDC3251, Lot Number 23IBU982 ; DYNDC3251, Lot Number 23JMB414 ; DYNDC3251, Lot Number 23LME615 ; DYNDC3251H , Lot Number 22IBG587 ; DYNDC3251H , Lot Number 23JMB414 ; DYNDC3251H , Lot Number 23LME615 ; DYNDC3251H , Lot Number 22LBK717 ; DYNDC3251H , Lot Number 23CBO992 ; DYNDC3251H , Lot Number 23EBM260 ; DYNDC3251H , Lot Number 23FBJ618 ; DYNDC3251H , Lot Number 23GBW852 ; DYNDC3251H , Lot Number 23HBU309 ; DYNDC3251H , Lot Number 23IBU982 ; DYNDC3255, Lot Number 23ABD853 ; DYNDC3255, Lot Number 23FBP898 ; DYNDC3255, Lot Number 23HBC286 ; DYNDC3255, Lot Number 23JBD836 ; DYNDC3255, Lot Number 23KBH344 ; DYNDC3255, Lot Number 23LBB005 ; DYNDC3263, Lot Number 22JBE153 ; DYNDC3263, Lot Number 22KBQ163 ; DYNDC3263, Lot Number 23ABS362 ; DYNDC3263, Lot Number 23BBB034 ; DYNDC3263, Lot Number 23BBU127 ; DYNDC3263, Lot Number 23EBM517 ; DYNDC3263, Lot Number 23IBE436 ; DYNDC3263, Lot Number 23JMJ790 ; DYNDC3263, Lot Number 23KMB878 ; DYNDC3263H , Lot Number 22JBE153 ; DYNDC3263H , Lot Number 23JMJ790 ; DYNDC3263H , Lot Number 23KMB878 ; DYNDC3263H , Lot Number 22KBQ163 ; DYNDC3263H , Lot Number 23ABS362 ; DYNDC3263H , Lot Number 23BBB034 ; DYNDC3263H , Lot Number 23BBU127 ; DYNDC3263H , Lot Number 23EBM517 ; DYNDC3263H , Lot Number 23IBE436 ; DYNDH1052A , Lot Number 23BBG409 ; DYNDH1052A , Lot Number 23EBD688 ; DYNDH1052A , Lot Number 23HBU300 ; DYNDH1052A , Lot Number 23JBQ041 ; DYNDH1123B , Lot Number 21JBT694 ; DYNDH1123BH, Lot Number 21JBT694 ; DYNDH1275, Lot Number 21EBQ424; DYNDH1275, Lot Number 21CBD008; DYNDH1275, Lot Number 21ABI951; DYNDH1395A , Lot Number 21JBJ563 ; DYNDH1395A , Lot Number 21LBO085 ; DYNDH1395A , Lot Number 22CBY447 ; DYNDH1395A , Lot Number 22JBI559 ; DYNDH1395A , Lot Number 22KBV270 ; DYNDH1395A , Lot Number 19JBN294 ; DYNDH1395A , Lot Number 23BBP230 ; DYNDH1395A , Lot Number 20ABX701 ; DYNDH1395A , Lot Number 23EBT269 ; DYNDH1395A , Lot Number 23FBM815 ; DYNDH1395A , Lot Number 23IBA665 ; DYNDH1395A , Lot Number 23JBN121 ; DYNDH1395A , Lot Number 23JBN316 ; DYNDH1395A , Lot Number 20JBZ510 ; DYNDH1395A , Lot Number 20KBX219 ; DYNDH1395A , Lot Number 20XBI828 ; DYNDH1395A , Lot Number 21CBW633 ; DYNDH1395A , Lot Number 21DBN997 ; DYNDH1636, Lot Number 23GBO820 ; DYNDH1636, Lot Number 23GBP897 ; DYNDH1636, Lot Number 23KBX519 ; DYNDH1654, Lot Number 21JBM327 ; DYNDH1654, Lot Number 21JBQ373 ; DYNDH1707, Lot Number 22EBE237 ; DYNDH1707, Lot Number 22JBI560 ; DYNDH1707, Lot Number 23EBU407 ; DYNDH1707, Lot Number 23FBF407 ; DYNDH1818, Lot Number 23AMH342 ; DYNDH1818, Lot Number 23DMI187 ; DYNDH1818, Lot Number 24AMA444 ; DYNDH1818H , Lot Number 23AMH342 ; DYNDH1818H , Lot Number 23DMI187 ; DYNDH1818H , Lot Number 24AMA444 ; DYNDH1833, Lot Number 23BBG411 ; DYNDH1833, Lot Number 23DBH315 ; DYNDH1833, Lot Number 23KBG118 ; DYNDH1904, Lot Number 23KBN988 ; DYNDH1905, Lot Number 23JBU154 ; DYNDH1915, Lot Number 23JBU024 ; DYNDH1922, Lot Number 23LBD324 ; DYNDL1508, Lot Number 2022061690; DYNDL1748, Lot Number 21JBI834 ; DYNJ00281M , Lot Number 19BBK226 ; DYNJ00281M , Lot Number 19DBV940 ; DYNJ00281M , Lot Number 19EBW249 ; DYNJ00281M , Lot Number 19FBJ668 ; DYNJ00281M , Lot Number 19JBD521 ; DYNJ00281M , Lot Number 19JBI229 ; DYNJ00281M , Lot Number 19VBA470 ; DYNJ00281M , Lot Number 20HMD357 ; DYNJ00281M , Lot Number 20IMB300 ; DYNJ00281M , Lot Number 20JMA297 ; DYNJ00281O , Lot Number 21GME986 ; DYNJ00281O , Lot Number 21HMF322 ; DYNJ00281O , Lot Number 21IMB331 ; DYNJ00281O , Lot Number 21JMD395 ; DYNJ00281O , Lot Number 21JMG983 ; DYNJ00281O , Lot Number 21KMH945 ; DYNJ00281O , Lot Number 22CMH221 ; DYNJ00281O , Lot Number 22FMD671 ; DYNJ00281O , Lot Number 22KMA417 ; DYNJ00281O , Lot Number 23EMA749 ; DYNJ00281P, Lot Number 24CMB320; DYNJ00281P , Lot Number 23GMD333 ; DYNJ00281P , Lot Number 23HMC426 ; DYNJ00281P , Lot Number 23JMH441 ; DYNJ0101291C , Lot Number 19HDA408 ; DYNJ0101291C , Lot Number 19IDA590 ; DYNJ0101291C , Lot Number 19JDC821 ; DYNJ0101291C , Lot Number 20ADB652 ; DYNJ0101291C , Lot Number 20BDA365 ; DYNJ0101291C , Lot Number 20CDC635 ; DYNJ0101291C , Lot Number 20EDA810 ; DYNJ0101291C , Lot Number 19AKD218 ; DYNJ0101291C , Lot Number 19CKA581 ; DYNJ0101291F , Lot Number 22KDB751 ; DYNJ0101291F , Lot Number 23EDA119 ; DYNJ0101291F , Lot Number 23EDB388 ; DYNJ0101291F , Lot Number 23FDA396 ; DYNJ0101291F , Lot Number 23GDA313 ; DYNJ0101291F , Lot Number 23HDA759 ; DYNJ0101291F , Lot Number 23LDB909 ; DYNJ0117497G , Lot Number 21FBI072 ; DYNJ0117497G , Lot Number 21GBA846 ; DYNJ0117497G , Lot Number 21GBE684 ; DYNJ0117497G , Lot Number 21HBA351 ; DYNJ0117497G , Lot Number 21IBP593 ; DYNJ0131782F , Lot Number 20JMC859 ; DYNJ0131782F , Lot Number 20LMD690 ; DYNJ0131782F , Lot Number 21CMD799 ; DYNJ0131782F , Lot Number 21HMC433 ; DYNJ0131782F , Lot Number 21IMF943 ; DYNJ0131782F , Lot Number 21JMA367 ; DYNJ0131782F , Lot Number 21KMB566 ; DYNJ0131782F , Lot Number 21KMC323 ; DYNJ0131782F , Lot Number 21LME348 ; DYNJ0131782F , Lot Number 20FKA867 ; DYNJ0150250A , Lot Number 19BBO827 ; DYNJ0150250A , Lot Number 19EBL020 ; DYNJ0151111C , Lot Number 23DDB304 ; DYNJ0151111C , Lot Number 23FDC146 ; DYNJ0151111C , Lot Number 23HDA363 ; DYNJ0151111C , Lot Number 23IDA769 ; DYNJ0151111C , Lot Number 23JDB197 ; DYNJ0151111C , Lot Number 23KDB580 ; DYNJ0151111C , Lot Number 24BDA016 ; DYNJ0160348B , Lot Number 19BDC775 ; DYNJ0160348B , Lot Number 19DDC820 ; DYNJ0160348B , Lot Number 19KDB134 ; DYNJ0160348B , Lot Number 20BDB971 ; DYNJ0160348B , Lot Number 20CDA536 ; DYNJ0160348B , Lot Number 20CDB453 ; DYNJ0160348B , Lot Number 20GDA597 ; DYNJ0160348B , Lot Number 21BDB946 ; DYNJ0160348B , Lot Number 21HDA843 ; DYNJ0160348B , Lot Number 21KDA674 ; DYNJ0160348B , Lot Number 22ADB771 ; DYNJ0160348B , Lot Number 22EDB536 ; DYNJ0160348B , Lot Number 22GDA289 ; DYNJ0160348B , Lot Number 22IDB621 ; DYNJ0160348B , Lot Number 23HDA183 ; DYNJ0160348B , Lot Number 23KDC246 ; DYNJ0161284, Lot Number 23HDC638; DYNJ0161284, Lot Number 23GDA353; DYNJ0161284, Lot Number 23FDB695; DYNJ0161284, Lot Number 22IDC075; DYNJ0161284, Lot Number 22FDB323; DYNJ0161284, Lot Number 22EDB436; DYNJ0161316A , Lot Number 19ADC362 ; DYNJ0161316A , Lot Number 19BDD339 ; DYNJ0161316A , Lot Number 19EDB771 ; DYNJ0161316A , Lot Number 19GDA928 ; DYNJ0161316A , Lot Number 19HDA271 ; DYNJ01613

Distribution pattern

Worldwide distribution.

device · product 18 of 81

Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Number 00-400832O ; 6) BIOPSY PROCEDURE PACK , Pack Number 00-400832P ; 7) BIOPSY PROCEDURE PACK , Pack Number 00-401261F ; 8) 6" FEMORAL ARTERIALLINE KIT, Pack Number ART245B; 9) BREAST BIOPSY KIT , Pack Number BT1085A; 10) BREAST BIOPSY PROCEDURE TRAY, Pack Number BX8375F; 11) BREAST/MINOR, Pack Number CDS980228X ; 12) BIOPSY CDS-LF , Pack Number CDS984667D ; 13) BIOPSY CDS-LF , Pack Number CDS984667F ; 14) BREAST-HERNIA-PORT CDS-LF , Pack Number CDS984853G ; 15) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 16) QSUM STEREO/US BIOPSY TRAY, Pack Number CT101; 17) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960; 18) BIOPSY DEKALB PACK, Pack Number DM150A ; 19) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 20) COLONOSCOPY KIT , Pack Number DYKE1218 ; 21) BREAST BIOPSY KIT , Pack Number DYNDA1224B ; 22) TDC REMOVAL, Pack Number DYNDA1633A; 23) BREAST BIOPSY PACK, Pack Number DYNDA2378A ; 24) CUSTOM BIOPSY TRAY, Pack Number DYNDA2448; 25) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 26) BIOPSY/MYELOGRAM PACK, Pack Number DYNDA2655; 27) PICU LINE TRAY, Pack Number DYNDC1960A; 28) PORT ACCESS KIT, Pack Number DYNDC2945; 29) CT BIOPSY TRAY, Pack Number DYNDH1054; 30) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 31) BIOPSY PACK , Pack Number DYNDH1110; 32) ARTHROGRAM TRAY, Pack Number DYNDH1113; 33) BIOPSY TRAY , Pack Number DYNDH1114; 34) BIOPSY TRAY, Pack Number DYNDH1129; 35) ARTHROGRAM TRAY, Pack Number DYNDH1134; 36) BIOPSY PACK , Pack Number DYNDH1137A ; 37) BREAST BIOPSY TRAY, Pack Number DYNDH1142C ; 38) BREAST BIOPSY TRAY, Pack Number DYNDH1152A ; 39) BIOPSY KIT, Pack Number DYNDH1156; 40) ULTRASOUND TRAY, Pack Number DYNDH1204; 41) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 42) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 43) CORE BIOPSY TRAY, Pack Number DYNDH1233; 44) BIOPSY PACK, Pack Number DYNDH1248; 45) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 46) BREAST BIOPSY TRAY, Pack Number DYNDH1266; 47) GENERAL BIOPSY TRAY , Pack Number DYNDH1268; 48) BIOPSY TRAY, Pack Number DYNDH1269; 49) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 50) DB CT BIOPSY TRAY -LF , Pack Number DYNDH1270; 51) BIOPSY TRAY , Pack Number DYNDH1273; 52) BIOPSY PACK TAA COMPLIANT , Pack Number DYNDH1294; 53) BREAST BIOPSY TRAY, Pack Number DYNDH1296B ; 54) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 55) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 56) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 57) BREAST BIOPSY TRAY, Pack Number DYNDH1302; 58) BREAST BIOPSY TRAY, Pack Number DYNDH1302H ; 59) BIOPSY TRAY, Pack Number DYNDH1314; 60) BIOPSY TRAY , Pack Number DYNDH1314A ; 61) MAMMOGRAPHY BREAST BIOPSY, Pack Number DYNDH1318; 62) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 63) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324; 64) BIOPSY TRAY, Pack Number DYNDH1328; 65) CT BIOPSY TRAY, Pack Number DYNDH1355A ; 66) BONE MARROW BIOPSY ASPIRATION , Pack Number DYNDH1376A ; 67) BREAST BIOPSY PACK, Pack Number DYNDH1425; 68) THYROID BIOPSY PACK , Pack Number DYNDH1430A ; 69) BONE MARROW BIOPSY KIT, Pack Number DYNDH1434; 70) SOFT TISSUE BIOPSY, Pack Number DYNDH1477; 71) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496A ; 72) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496AH; 73) BREAST BIOPSY , Pack Number DYNDH1518A ; 74) BIOPSY, Pack Number DYNDH1543; 75) BIOPSY PACK , Pack Number DYNDH1556; 76) BIOPSY PACK , Pack Number DYNDH1556D ; 77) IR BIOPSY TRAY, Pack Number DYNDH1569; 78) BIOPSY KIT, Pack Number DYNDH1570; 79) STEREOTACTIC BIOPSY , Pack Number DYNDH1572; 80) ULTRASOUND BIOPSY , Pack Number DYNDH1573A ; 81) BREAST BIOPSY , Pack Number DYNDH1575; 82) CT BIOP

Z-2998-2024
Recall number
Z-2998-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

00-400162J, Lot Number 24BMJ154; 00-400162J , Lot Number 21HBM269 ; 00-400162J , Lot Number 21IBK734 ; 00-400162J , Lot Number 21VBB786 ; 00-400162J , Lot Number 21KBS936 ; 00-400162J , Lot Number 21LBA763 ; 00-400162J , Lot Number 22ABN222 ; 00-400162J , Lot Number 19ABM483 ; 00-400162J , Lot Number 19BBI451 ; 00-400162J , Lot Number 19CBM173 ; 00-400162J , Lot Number 19DBL959 ; 00-400162J , Lot Number 22FBO944 ; 00-400162J , Lot Number 19FBG533 ; 00-400162J , Lot Number 22JBB402 ; 00-400162J , Lot Number 19TBB201 ; 00-400162J , Lot Number 22KBV632 ; 00-400162J , Lot Number 19JBD745 ; 00-400162J , Lot Number 19KBI828 ; 00-400162J , Lot Number 19LBK452 ; 00-400162J , Lot Number 23CBO907 ; 00-400162J , Lot Number 19LBY367 ; 00-400162J , Lot Number 20ABQ389 ; 00-400162J , Lot Number 23FBG349 ; 00-400162J , Lot Number 20CBV380 ; 00-400162J , Lot Number 20DBI320 ; 00-400162J , Lot Number 23IBF372 ; 00-400162J , Lot Number 20FBQ675 ; 00-400162J , Lot Number 20GBO378 ; 00-400162J , Lot Number 20JBH095 ; 00-400162J , Lot Number 20JBL452 ; 00-400162J , Lot Number 20JBX151 ; 00-400162J , Lot Number 20KBZ223 ; 00-400162J , Lot Number 20XBA215 ; 00-400162J , Lot Number 21DBB680 ; 00-400162J , Lot Number 24AMB898 ; 00-400405C , Lot Number 21KBM812 ; 00-400405C , Lot Number 21LBT408 ; 00-400405C , Lot Number 21LBT899 ; 00-400405C , Lot Number 19ABL059 ; 00-400405C , Lot Number 19BBB783 ; 00-400405C , Lot Number 19CBC868 ; 00-400405C , Lot Number 19KBY105 ; 00-400405C , Lot Number 19LBB184 ; 00-400762H , Lot Number 21HBR227 ; 00-400832N , Lot Number 19BDA790 ; 00-400832N , Lot Number 19BDD147 ; 00-400832N , Lot Number 19DDB220 ; 00-400832N , Lot Number 19FDA964 ; 00-400832O , Lot Number 19IDA318 ; 00-400832O , Lot Number 19KMA743 ; 00-400832O , Lot Number 19KMC836 ; 00-400832O , Lot Number 20BMA017 ; 00-400832O , Lot Number 20CMB031 ; 00-400832O , Lot Number 20FMB526 ; 00-400832O , Lot Number 20HMC867 ; 00-400832O , Lot Number 20JMB320 ; 00-400832O , Lot Number 21AMC858 ; 00-400832O , Lot Number 21FMA865 ; 00-400832O , Lot Number 21HMB368 ; 00-400832O , Lot Number 21JMA868 ; 00-400832O , Lot Number 22AME715 ; 00-400832O , Lot Number 22CMA957 ; 00-400832P , Lot Number 23LBL872 ; 00-400832P , Lot Number 22EMF901 ; 00-400832P , Lot Number 22GMD199 ; 00-400832P , Lot Number 22HME947 ; 00-400832P , Lot Number 22JMA494 ; 00-400832P , Lot Number 22KMD610 ; 00-400832P , Lot Number 23AMB199 ; 00-400832P , Lot Number 23CMD961 ; 00-400832P , Lot Number 23EMD513 ; 00-400832P , Lot Number 23FMH541 ; 00-400832P , Lot Number 23GMH251 ; 00-400832P , Lot Number 23IMA234 ; 00-400832P , Lot Number 23KMA301 ; 00-401261F , Lot Number 19DDD151 ; ART245B, Lot Number 2023050490; BT1085A, Lot Number 21JBW716 ; BT1085A, Lot Number 22EBN971 ; BT1085A, Lot Number 22IBO409 ; BT1085A, Lot Number 22KBQ151 ; BT1085A, Lot Number 22LBS928 ; BT1085A, Lot Number 23EBQ469 ; BT1085A, Lot Number 23HBA899 ; BT1085A, Lot Number 23HBM503 ; BT1085A, Lot Number 23LBP500 ; BX8375F, Lot Number 19BBQ976 ; CDS980228X , Lot Number 21IBJ198 ; CDS980228X , Lot Number 21IBL102 ; CDS980228X , Lot Number 21IBT611 ; CDS980228X , Lot Number 21KBA518 ; CDS980228X , Lot Number 22CBT672 ; CDS980228X , Lot Number 22OBL706 ; CDS980228X , Lot Number 22EBN150 ; CDS980228X , Lot Number 22GBJ007 ; CDS980228X , Lot Number 22GBJ522 ; CDS980228X , Lot Number 22GBU493 ; CDS980228X , Lot Number 22HBO646 ; CDS980228X , Lot Number 22JBH336 ; CDS980228X , Lot Number 22KBI846 ; CDS980228X , Lot Number 23BBB687 ; CDS980228X , Lot Number 23BBB770 ; CDS980228X , Lot Number 23CBQ216 ; CDS980228X , Lot Number 23EBG155 ; CDS980228X , Lot Number 23FBH110 ; CDS980228X , Lot Number 23FBU678 ; CDS980228X , Lot Number 23HBK342 ; CDS980228X , Lot Number 23IBM309 ; CDS980228X , Lot Number 23KBN911 ; CDS980228X , Lot Number 23LBQ885 ; CDS980228X , Lot Number 24ABV909 ; CDS984667D , Lot Number 19ABX202 ; CDS984667D , Lot Number 19CBJ247 ; CDS984667D , Lot Number 19EBK219 ; CDS984667D , Lot Number 19GBH803 ; CDS984667D , Lot Number 19HBM191 ; CDS984667D , Lot Number 19KBR426 ; CDS984667D , Lot Number 20BBD375 ; CDS984667D , Lot Number 20BBW882 ; CDS984667D , Lot Number 20FBL632 ; CDS984667D , Lot Number 20HBI802 ; CDS984667D , Lot Number 20JBH644 ; CDS984667D , Lot Number 21ABW316 ; CDS984667D , Lot Number 21BBO832 ; CDS984667F , Lot Number 21HBI147 ; CDS984667F , Lot Number 21HBQ079 ; CDS984667F , Lot Number 21IBC923 ; CDS984667F , Lot Number 21JBC107 ; CDS984667F , Lot Number 21JBM708 ; CDS984667F , Lot Number 21LBG294 ; CDS984667F , Lot Number 22NBF721 ; CDS984667F , Lot Number 22OBJ844 ; CDS984667F , Lot Number 21EBC591 ; CDS984667F , Lot Number 22FMH829 ; CDS984667F , Lot Number 22HMA231 ; CDS984667F , Lot Number 22JMB506 ; CDS984667F , Lot Number 22JMG035 ; CDS984667F , Lot Number 22KMC059 ; CDS984667F , Lot Number 22LME009 ; CDS984667F , Lot Number 23AMF563 ; CDS984667F , Lot Number 23CMD811 ; CDS984667F , Lot Number 23CMG538 ; CDS984667F , Lot Number 23FMC037 ; CDS984667F , Lot Number 23GMA593 ; CDS984853G , Lot Number 21JDB293 ; CDS984853G , Lot Number 21KDB427 ; 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DYNDH1543, Lot Number 20LBY288 ; DYNDH1543, Lot Number 21DBG368 ; DYNDH1543, Lot Number 23LME333 ; DYNDH1556, Lot Number 21ALA440 ; DYNDH1556, Lot Number 21BLA324 ; DYNDH1556, Lot Number 21FLA148 ; DYNDH1556, Lot Number 21GLA580 ; DYNDH1556, Lot Number 21GLB216 ; DYNDH1556, Lot Number 21HLA735 ; DYNDH1556D , Lot Number 23AMD344 ; DYNDH1556D , Lot Number 23BMD467 ; DYNDH1556D , Lot Number 23BME709 ; DYNDH1556D , Lot Number 23EMA743 ; DYNDH1556D , Lot Number 23FMG663 ; DYNDH1556D , Lot Number 23GMH911 ; DYNDH1556D , Lot Number 23HMF214 ; DYNDH1556D , Lot Number 23JMA504 ; DYNDH1556D , Lot Number 23JME016 ; DYNDH1569, Lot Number 21HBF353 ; DYNDH1569, Lot Number 21IBH472 ; DYNDH1569, Lot Number 21KBT984 ; DYNDH1569, Lot Number 21LBR408 ; DYNDH1569, Lot Number 22ABU583 ; DYNDH1569, Lot Number 22BBP397 ; DYNDH1569, Lot Number 22DBD267 ; DYNDH1569, Lot Number 22IBB957 ; DYNDH1569, Lot Number 22JBA134 ; DYNDH1569, Lot Number 22KBA732 ; DYNDH1569, Lot Number 20JBC111 ; DYNDH1569, Lot Number 20JBF234 ; DYNDH1570, Lot Number 2020112550; DYNDH1570, Lot Number 2021011450; DYNDH1572, Lot Number 21HBO776 ; DYNDH1572, Lot Number 21JBV510 ; DYNDH1573A , Lot Number 23ELA142 ; DYNDH1573A , Lot Number 23ILA120 ; DYNDH1573A , Lot Number 23KLA560 ; DYNDH1573A , Lot Number 23LLB010 ; DYNDH1575, Lot Number 21JBR477 ; DYNDH1580, Lot Number 2020121750; DYNDH1580, Lot Number 2021112350; DYNDH1580, Lot Number 2022010550; DYNDH1580A , Lot Number 22DBJ897 ; DYNDH1580A , Lot Number 23CBL844 ; DYNDH1580A , Lot Number 23DBE202 ; DYNDH1580A , Lot Number 23HBA151 ; DYNDH1580A , Lot Number 23HBN482 ; DYNDH1580A , Lot Number 23HBZ413 ; DYNDH1580A , Lot Number 23LBL385 ; DYNDH1584, Lot Number 21JBG956 ; DYNDH1584, Lot Number 21JBR574 ; DYNDH1586, Lot Number 21JBV399 ; DYNDH1588, Lot Number 23GBJ013 ; DYNDH1588, Lot Number 23LBV272 ; DYNDH1595, Lot Number 21JBD963 ; DYNDH1595, Lot Number 22ABC771 ; DYNDH1595, Lot Number 22GBH603 ; DYNDH1595, Lot Number 22HBP445 ; DYNDH1595, Lot Number 22LBS940 ; DYNDH1595, Lot Number 23HBA885 ; DYNDH1595, Lot Number 21ABW595 ; DYNDH1595, Lot Number 21CBP433 ; DYNDH1595, Lot Number 21CBR509 ; DYNDH1595, Lot Number 23JMC270 ; DYNDH1602, Lot Number 22OBG033 ; DYNDH1602, Lot Number 22EBE280 ; DYNDH1602, Lot Number 22EBN958 ; DYNDH1602, Lot Number 22GBO524 ; DYNDH1602, Lot Number 22HBE597 ; DYNDH1602, Lot Number 22JBP820 ; DYNDH1602, Lot Number 22KBU720 ; DYNDH1602, Lot Number 22LBT376 ; DYNDH1602, Lot Number 23DBA127 ; DYNDH1602, Lot Number 23EBI215 ; DYNDH1602, Lot Number 23GBM251 ; DYNDH1602, Lot Number 23HBH574 ; DYNDH1602, Lot Number 23HBM502 ; DYNDH1602, Lot Number 23JBH195 ; DYNDH1602, Lot Number 23KBV025 ; DYNDH1602, Lot Number 24ABW160 ; DYNDH1613, Lot Number 24BLA214; DYNDH1613, Lot Number 23ILA052; DYNDH1613, Lot Number 23HLB206; DYNDH1613, Lot Number 23DLA797; DYNDH1624, Lot Number 22HLB337; DYNDH1631, Lot Number 23JMG570 ; DYNDH1634A, Lot Number 24BMD983; DYNDH1634A, Lot Number 23LMC573; DYNDH1634A, Lot Number 23JMB413; DYNDH1634A, Lot Number 23IMG504; DYNDH1634A, Lot Number 23FMH874; DYNDH1634A, Lot Number 23EMJ632; DYNDH1634A, Lot Number 23DMG721; DYNDH1634A, Lot Number 23CMA356; DYNDH1634A, Lot Number 23AMH736; DYNDH1634A, Lot Number 22KMB231; DYNDH1638, Lot Number 22IBT566 ; DYNDH1638, Lot Number 22LBK960 ; DYNDH1638, Lot Number 23GBH994 ; DYNDH1638, Lot Number 23IBS435 ; DYNDH1638, Lot Number 23KBG132 ; DYNDH1667, Lot Number 22ABT665 ; DYNDH1667, Lot Number 22DBB281 ; DYNDH1667, Lot Number 22DBB282 ; DYNDH1667, Lot Number 23CBR899 ; DYNDH1670, Lot Number 22DBO815 ; DYNDH1670, Lot Number 23CBN588 ; DYNDH1670, Lot Number 23DBE647 ; DYNDH1670, Lot Number 23EBU374 ; DYNDH1670, Lot Number 23HBH896 ; DYNDH1670, Lot Number 23IBG199 ; DYNDH1670, Lot Number 23LBJ537 ; DYNDH1677, Lot Number 22BBJ243 ; DYNDH1677, Lot Number 22DBA012 ; DYNDH1677, Lot Number 22FBF376 ; DYNDH1677, Lot Number 22FBL871 ; DYNDH1677, Lot Number 22GBX077 ; DYNDH1677, Lot Number 22HBK787 ; DYNDH1677, Lot Number 22IBO428 ; DYNDH1677, Lot Number 22JBB509 ; DYNDH1677, Lot Number 22KBU074 ; DYNDH1677, Lot Number 23EBU370 ; DYNDH1677, Lot Number 23FBV504 ; DYNDH1677, Lot Number 23GBS173 ; DYNDH1677, Lot Number 23HBA923 ; DYNDH1677, Lot Number 23LBQ555 ; DYNDH1677, Lot Number 24ABT498 ; DYNDH1678, Lot Number 23LBN551 ; DYNDH1679, Lot Number 23JBV019; DYNDH1679, Lot Number 22FBI748; DYNDH1679, Lot Number 22EBD378; DYNDH1679, Lot Number 22ABF639; DYNDH1682, Lot Number 23JBH200 ; DYNDH1682, Lot Number 23LBN552 ; DYNDH1684, Lot Number 22ABZ125 ; DYNDH1684, Lot Number 22EBH057 ; DYNDH1689, Lot Number 22IBN706; DYNDH1690, Lot Number 22OBD979 ; DYNDH1690, Lot Number 22EBD663 ; DYNDH1690, Lot Number 22EBQ187 ; DYNDH1690, Lot Number 23CBW703 ; DYNDH1690, Lot Number 23EBM585 ; DYNDH1690, Lot Number 23GBC573 ; DYNDH1690, Lot Number 23HBW911 ; DYNDH1690, Lot Number 23KBK338 ; DYNDH1690, Lot Number 24ABU831 ; DYNDH1693A , Lot Number 22HBK639 ; DYNDH1693A , Lot Number 23BBU060 ; DYNDH1706, Lot Number 23GLA058 ; DYNDH1706, Lot Number 24CLA291 ; DYNDH1711, Lot Number 22GBH312 ; DYNDH1711, Lot Number 23HBJ937 ; DYNDH1711, Lot Number 23JBR945 ; DYNDH1711, Lot Number 24ABC623 ; DYNDH1736, Lot Number 23HBM215 ; DYNDH1750, Lot Number 22GBY766 ; DYNDH1750, Lot Number 22LBA031 ; DYNDH1750, Lot Number 22LBA725 ; DYNDH1750, Lot Number 23ABQ597 ; DYNDH1750A , Lot Number 23CBC545 ; DYNDH1750A , Lot Number 23CBF309 ; DYNDH1750A , Lot Number 23DBA122 ; DYNDH1750A , Lot Number 23HBX164 ; DYNDH1750A , Lot Number 23JBS504 ; DYNDH1750A , Lot Number 23JBY271 ; DYNDH1750A , Lot Number 23KBT554 ; DYNDH1755, Lot Number 23DLA934 ; DYNDH1755, Lot Number 23DLB012 ; DYNDH1755, Lot Number 23ELA938 ; DYNDH1755, Lot Number 23JLA346 ; DYNDH1755, Lot Number 23KLA549 ; DYNDH1755, Lot Number 23LLA435 ; DYNDH1755, Lot Number 24ALA486 ; DYNDH1764, Lot Number 22HBF813 ; DYNDH1764, Lot Number 22IBS384 ; DYNDH1764, Lot Number 22KBC678 ; DYNDH1764, Lot Number 22KBK735 ; DYNDH1764, Lot Number 22KBU113 ; DYNDH1764, Lot Number 23ABL673 ; DYNDH1764, Lot Number 23BBF906 ; DYNDH1764, Lot Number 23BBU153 ; DYNDH1764, Lot Number 23EBN630 ; DYNDH1764, Lot Number 23EBT611 ; DYNDH1764, Lot Number 23GBM269 ; DYNDH1764, Lot Number 23HBW853 ; DYNDH1764, Lot Number 23KBP918 ; DYNDH1766, Lot Number 22HBC593 ; DYNDH1766, Lot Number 22HBD206 ; DYNDH1766, Lot Number 22IBV365 ; DYNDH1766, Lot Number 23KBX520 ; DYNDH1767, Lot Number 22JLB049 ; DYNDH1767, Lot Number 22LLA744 ; DYNDH1767, Lot Number 23ELB012 ; DYNDH1767, Lot Number 23FLA343 ; DYNDH1767, Lot Number 23HLA368 ; DYNDH1767, Lot Number 23JLA426 ; DYNDH1767, Lot Number 23KLA113 ; DYNDH1767, Lot Number 24ALA514 ; DYNDH1768, Lot Number 22JLB194 ; DYNDH1768, Lot Number 22LLA279 ; DYNDH1768, Lot Number 22LLA721 ; DYNDH1783, Lot Number 23KBQ136; DYNDH1783, Lot Number 23JBD841; DYNDH1783, Lot Number 23GBO536; DYNDH1783, Lot Number 23EBD434; DYNDH1783, Lot Number 23CBQ480; DYNDH1783, Lot Number 22LBB197; DYNDH1785, Lot Number 23ABD268 ; DYNDH1785, Lot Number 23JBK595 ; DYNDH1785, Lot Number 23KBO086 ; DYNDH1790, Lot Number 24BME095; DYNDH1790, Lot Number 22IBQ468 ; DYNDH1790, Lot Number 22KBU685 ; DYNDH1790, Lot Number 23FBT558 ; DYNDH1790, Lot Number 23GBO509 ; DYNDH1790, Lot Number 23IMI126 ; DYNDH1790, Lot Number 23JMG228 ; DYNDH1790, Lot Number 23JMJ471 ; DYNDH1790H, Lot Number 24BME095; DYNDH1790H , Lot Number 23IMI126 ; DYNDH1790H , Lot Number 22IBQ468 ; DYNDH1790H , Lot Number 23JMG228 ; DYNDH1790H , Lot Number 23JMJ471 ; DYNDH1790H , Lot Number 22KBU685 ; DYNDH1790H , Lot Number 23FBT558 ; DYNDH1790H , Lot Number 23GBO509 ; DYNDH1791, Lot Number 22KBC806 ; DYNDH1791, Lot Number 22KBW507 ; DYNDH1791, Lot Number 23FBF338 ; DYNDH1791, Lot Number 23FBV505 ; DYNDH1791, Lot Number 23HBA925 ; DYNDH1791, Lot Number 23JMJ664 ; DYNDH1791, Lot Number 23KME447 ; DYNDH1791, Lot Number 23KMF875 ; DYNDH1791H , Lot Number 23JMJ664 ; DYNDH1791H , Lot Number 23KME447 ; DYNDH1791H , Lot Number 23KMF875 ; DYNDH1791H , Lot Number 22KBC806 ; DYNDH1791H , Lot Number 22KBW507 ; DYNDH1791H , Lot Number 23FBF338 ; DYNDH1791H , Lot Number 23FBV505 ; DYNDH1791H , Lot Number 23HBA925 ; DYNDH1792, Lot Number 22LBD494 ; DYNDH1792, Lot Number 23ABG084 ; DYNDH1792, Lot Number 23KMB880 ; DYNDH1792, Lot Number 24AMB500 ; DYNDH1792H , Lot Number 23KMB880 ; DYNDH1792H , Lot Number 24AMB500 ; DYNDH1792H , Lot Number 22LBD494 ; DYNDH1792H , Lot Number 23ABG084 ; DYNDH1806, Lot Number 22LBJ085 ; DYNDH1806, Lot Number 23EBT549 ; DYNDH1806, Lot Number 23FBI307 ; DYNDH1806A , Lot Number 23HBU115 ; DYNDH1806A , Lot Number 23JBD884 ; DYNDH1806A , Lot Number 23KBL590 ; DYNDH1808, Lot Number 23ABA038 ; DYNDH1808, Lot Number 23CBV045 ; DYNDH1808, Lot Number 23DBA137 ; DYNDH1808A , Lot Number 23IBO822 ; DYNDH1810, Lot Number 23AMB225 ; DYNDH1810, Lot Number 23AMB458 ; DYNDH1810, Lot Number 23AMG119 ; DYNDH1813, Lot Number 23ALA857 ; DYNDH1813, Lot Number 23CLB196 ; DYNDH1813, Lot Number 23ELA393 ; DYNDH1813, Lot Number 23GLA955 ; DYNDH1813A , Lot Number 23JLA144 ; DYNDH1813A , Lot Number 23KLA210 ; DYNDH1813A , Lot Number 24ALA973 ; DYNDH1813B , Lot Number 24CLA227 ; DYNDH1822, Lot Number 22LBK525 ; DYNDH1826, Lot Number 23BBR452 ; DYNDH1826, Lot Number 23EBL744 ; DYNDH1826, Lot Number 23FBK352 ; DYNDH1826, Lot Number 23FBM816 ; DYNDH1826A , Lot Number 23GBF728 ; DYNDH1826A , Lot Number 23GBG160 ; DYNDH1826A , Lot Number 23KBB029 ; DYNDH1826A , Lot Number 24ABD197 ; DYNDH1828, Lot Number 23CMA077 ; DYNDH1828, Lot Number 23GMA255 ; DYNDH1828, Lot Number 23GMH912 ; DYNDH1828, Lot Number 23IMB830 ; DYNDH1828, Lot Number 23JMJ009 ; DYNDH1828, Lot Number 23LMB027 ; DYNDH1828, Lot Number 23LME338 ; DYNDH1829, Lot Number 23CLB114 ; DYNDH1829, Lot Number 23ILA899 ; DYNDH1840, Lot Number 23BBP251 ; DYNDH1840, Lot Number 23GBT591 ; DYNDH1840, Lot Number 23KBD878 ; DYNDH1840, Lot Number 23LBL635 ; DYNDH1873, Lot Number 23KBK476 ; DYNDH1873, Lot Number 23KBU878 ; DYNDH1882, Lot Number 23HBT056 ; DYNDH1882, Lot Number 23JBY263 ; DYNDH1882, Lot Number 23LBM730 ; DYNDH1897, Lot Number 23IBJ112 ; DYNDH1897, Lot Number 23KBD754 ; DYNDH1897H , Lot Number 23IBJ112 ; DYNDH1897H , Lot Number 23KBD754 ; DYNDH1900, Lot Number 23JLA100 ; DYNDH1900, Lot Number 23LLA989 ; DYNDH1900, Lot Number 24ALA405 ; DYNDH1900, Lot Number 24BLA691 ; DYNDH1900, Lot Number 24CLA150 ; DYNDH1917, Lot Number 23JBH246 ; DYNDH1926, Lot Number 23IBS556 ; DYNDH1933, Lot Number 23LBF004 ; DYNDH1934, Lot Number 23LBQ888 ; DYNDH1947, Lot Number 24BMA307; DYNDL1159B, Lot Number 2019110480; DYNDL1461, Lot Number 2018061450; DYNDL1461, Lot Number 2020112550; DYNDL1462B, Lot Number 2020082850; DYNDL1462B, Lot Number 2021112350; DYNDL1462B , Lot Number 22IBN230 ; DYNDL1462B , Lot Number 22KBV206 ; DYNDL1462B , Lot Number 23BBA080 ; DYNDL1462B , Lot Number 23FBL601 ; DYNDL1462B , Lot Number 23GBK686 ; DYNDL1462B , Lot Number 23IBI080 ; DYNDL1462B , Lot Number 23KBD189 ; DYNDL1462BH, Lot Number 22IBN230 ; DYNDL1462BH, Lot Number 22KBV206 ; DYNDL1462BH, Lot Number 23BBA080 ; DYNDL1462BH, Lot Number 23FBL601 ; DYNDL1462BH, Lot Number 23GBK686 ; DYNDL1462BH, Lot Number 23IBI080 ; DYNDL1462BH, Lot Number 23KBD189 ; DYNDL1898, Lot Number 2018090750; DYNJ0101211G , Lot Number 22ADB103 ; DYNJ0101211G , Lot Number 22BDB367 ; DYNJ0101211G , Lot Number 22CDA362 ; DYNJ0101211I , Lot Number 22IDB407 ; DYNJ0101211I , Lot Number 23CDA452 ; DYNJ0101211I , Lot Number 23CDC712 ; DYNJ0101211I , Lot Number 23GDA047 ; DYNJ0101211I , Lot Number 23GDA934 ; DYNJ0101211I , Lot Number 23IDC339 ; DYNJ0101211I , Lot Number 24ADA374 ; DYNJ0101211I , Lot Number 24CDA052 ; DYNJ0155943G , Lot Number 20JMC695 ; DYNJ0155943G , Lot Number 21FMA077 ; DYNJ0155943G , Lot Number 21GMC749 ; DYNJ0155943G , Lot Number 21HME612 ; DYNJ0155943G , Lot Number 21KMH614 ; DYNJ0155943G , Lot Number 21LMG889 ; DYNJ0155943G , Lot Number 22LMD492 ; DYNJ0155943G , Lot Number 23EMA753 ; DYNJ0155943G , Lot Number 23FMH745 ; DYNJ0155943G , Lot Number 23JMJ246 ; DYNJ0155943G , Lot Number 23LME228 ; DYNJ0155943G , Lot Number 19AKC465 ; DYNJ0155943G , Lot Number 19CKB421 ; DYNJ0155943G , Lot Number 19EKA993 ; DYNJ0155943G , Lot Number 19GKA452 ; DYNJ0155943G , Lot Number 19HKB195 ; DYNJ0155943G , Lot Number 19IKA154 ; DYNJ0155943G , Lot Number 19JKA944 ; DYNJ0155943G , Lot Number 19KKA636 ; DYNJ0155943G , Lot Number 19KKA796 ; DYNJ0155943G , Lot Number 20GKA222 ; DYNJ0155943GH, Lot Number 21FMA077 ; DYNJ0155943GH, Lot Number 21GMC749 ; DYNJ0155943GH, Lot Number 21HME612 ; DYNJ0155943GH, Lot Number 19AKC465 ; DYNJ0155943GH, Lot Number 21KMH614 ; DYNJ0155943GH, Lot Number 19CKB421 ; DYNJ0155943GH, Lot Number 19EKA993 ; DYNJ0155943GH, Lot Number 21LMG889 ; DYNJ0155943GH, Lot Number 19GKA452 ; DYNJ0155943GH, Lot Number 19HKB195 ; DYNJ0155943GH, Lot Number 19IKA154 ; DYNJ0155943GH, Lot Number 19JKA944 ; DYNJ0155943GH, Lot Number 19KKA636 ; DYNJ0155943GH, Lot Number 19KKA796 ; DYNJ0155943GH, Lot Number 22LMD492 ; DYNJ0155943GH, Lot Number 23EMA753 ; DYNJ0155943GH, Lot Number 23FMH745 ; DYNJ0155943GH, Lot Number 23JMJ246 ; DYNJ0155943GH, Lot Number 23LME228 ; DYNJ0160598B , Lot Number 19BDD149 ; DYNJ0160598B , Lot Number 19EDC685 ; DYNJ0160598B , Lot Number 19HDB192 ; DYNJ0160598B , Lot Number 19JDB997 ; DYNJ0160598B , Lot Number 20ADA327 ; DYNJ0160598B , Lot Number 20ADD253 ; DYNJ0160598B , Lot Number 20DDB808 ; DYNJ0160598B , Lot Number 20JDB320 ; DYNJ0160598B , Lot Number 20LDA655 ; DYNJ0160598B , Lot Number 21CDA013 ; DYNJ0160598B , Lot Number 21CDC088 ; DYNJ0160598B , Lot Number 21GDC876 ; DYNJ0160598B , Lot Number 21HDC664 ; DYNJ0160598B , Lot Number 21KDC354 ; DYNJ0160598B , Lot Number 22BDA014 ; DYNJ0160598B , Lot Number 22BDC355 ; DYNJ0160598B , Lot Number 22EDA412 ; DYNJ0160598B , Lot Number 22GDB278 ; DYNJ0160598B , Lot Number 22HDA122 ; DYNJ0160598B , Lot Number 22IDB852 ; DYNJ0160598C , Lot Number 23ADA376 ; DYNJ0160598C , Lot Number 23ADB824 ; DYNJ0160598C , Lot Number 23DDA345 ; DYNJ0160598C , Lot Number 23DDC250 ; DYNJ0160598C , Lot Number 23GDA351 ; DYNJ0160598C , Lot Number 23HDC166 ; DYNJ0160598C , Lot Number 23KDB383 ; DYNJ0160598C , Lot Number 24BDB838 ; DYNJ0199955P , Lot Number 19AKB640 ; DYNJ0199955P , Lot Number 19BKC665 ; DYNJ0199955P , Lot Number 19DKB063 ; DYNJ0199955P , Lot Number 19EKC083 ; DYNJ0199955P , Lot Number 19GKB648 ; DYNJ0199955P , Lot Number 19IKA863 ; DYNJ0199955P , Lot Number 19JKB618 ; DYNJ0199955Q , Lot Number 20AKA264 ; DYNJ0199955Q , Lot Number 20DKA916 ; DYNJ0199955R , Lot Number 21ELA074 ; DYNJ0199955R , Lot Number 21FLA149 ; DYNJ0199955R , Lot Number 21HLA100 ; DYNJ0199955R , Lot Number 21JLA281 ; DYNJ0199955R , Lot Number 21LLA169 ; DYNJ0199955R , Lot Number 21LLA896 ; DYNJ0199955R , Lot Number 22BLA138 ; DYNJ0199955R , Lot Number 22CLA408 ; DYNJ0199955R , Lot Number 22CLA954 ; DYNJ0199955R , Lot Number 22DLA724 ; DYNJ0199955R , Lot Number 22ELA192 ; DYNJ0199955R , Lot Number 22ELA714 ; DYNJ0199955R , Lot Number 22FLA609 ; DYNJ0199955R , Lot Number 22GLA617 ; DYNJ0199955R , Lot Number 22HLB202 ; DYNJ0199955R , Lot Number 22JLB237 ; DYNJ0199955R , Lot Number 23ALA212 ; DYNJ0199955R , Lot Number 23ALB048 ; DYNJ0199955R , Lot Number 23BLB005 ; DYNJ0199955R , Lot Number 23DLB020 ; DYNJ0199955R , Lot Number 23ELA859 ; DYNJ0199955R , Lot Number 23FLA416 ; DYNJ0199955R , Lot Number 23GLA986 ; DYNJ0199955R , Lot Number 23HLA566 ; DYNJ0199955R , Lot Number 20FKB889 ; DYNJ0199955R , Lot Number 20JKA771 ; DYNJ0199955R , Lot Number 20LKA476 ; DYNJ0199955R , Lot Number 21CKA997 ; DYNJ0199955S , Lot Number 23ILA707 ; DYNJ0199955S , Lot Number 23KLA815 ; DYNJ0199955S , Lot Number 23LLA369 ; DYNJ0199955S , Lot Number 24ALA887 ; DYNJ0199955S , Lot Number 24CLA446 ; DYNJ0222342F , Lot Number 20KMB687 ; DYNJ0222342F , Lot Number 20KME173 ; DYNJ0222342F , Lot Number 21AMA371 ; DYNJ0222342F , Lot Number 21CMD210 ; DYNJ0222342F , Lot Number 21EMC456 ; DYNJ0222342F , Lot Number 21FMF534 ; DYNJ0222342F , Lot Number 21HMC133 ; DYNJ0222342F , Lot Number 21HMD610 ; DYNJ0222342F , Lot Number 21IMB911 ; DYNJ0222342F , Lot Number 22DMB025 ; DYNJ0222342F , Lot Number 22DMF844 ; DYNJ0222342F , Lot Number 22GMA755 ; DYNJ0222342F , Lot Number 22LMA964 ; DYNJ0222342F , Lot Number 22LMF471 ; DYNJ0222342F , Lot Number 23AMD263 ; DYNJ0222342F , Lot Number 23AMF496 ; DYNJ0222342F , Lot Number 23EME906 ; DYNJ0222342F , Lot Number 23GMB700 ; DYNJ0222342F , Lot Number 23HMC023 ; DYNJ0222342F , Lot Number 19AKA979 ; DYNJ0222342F , Lot Number 19BKB393 ; DYNJ0222342F , Lot Number 19DKC744 ; DYNJ0222342F , Lot Number 19GKD092 ; DYNJ0222342F , Lot Number 19HKD179 ; DYNJ0222342F , Lot Number 19JKA385 ; DYNJ0222342F , Lot Number 19KKA250 ; DYNJ0222342F , Lot Number 20AKA448 ; DYNJ0222342F , Lot Number 20CKB391 ; DYNJ0222342F , Lot Number 20FKA488 ; DYNJ0222342F , Lot Number 20GKB001 ; DYNJ0222342F , Lot Number 20IKA316 ; DYNJ0222342G, Lot Number 24BMJ281; DYNJ0222342G , Lot Number 23IMD321 ; DYNJ0222342G , Lot Number 23KMD134 ; DYNJ0222342G , Lot Number 23KMJ716 ; DYNJ0284020M , Lot Number 22DBG012 ; DYNJ0284020M , Lot Number 22DBI504 ; DYNJ0284020N , Lot Number 22IBT670 ; DYNJ0284020N , Lot Number 22JBK779 ; DYNJ0284020N , Lot Number 22KBK357 ; DYNJ0284020N , Lot Number 22KBK359 ; DYNJ0284020N , Lot Number 23BBE028 ; DYNJ0284020N , Lot Number 23CBP840 ; DYNJ0284020N , Lot Number 23DBR586 ; DYNJ0284020N , Lot Number 23EBP232 ; DYNJ0362304D , Lot Number 19ALA383 ; DYNJ0362304D , Lot Number 19BLA088 ; DYNJ0362304D , Lot Number 19DLA287 ; DYNJ0362304D , Lot Number 19ELA225 ; DYNJ0362304D , Lot Number 19ELA418 ; DYNJ0362304D , Lot Number 19ELA669 ; DYNJ0362304D , Lot Number 19GLA396 ; DYNJ0362304D , Lot Number 19ILA408 ; DYNJ0362304D , Lot Number 19JLA462 ; DYNJ0362304D , Lot Number 19KLA081 ; DYNJ0362304D , Lot Number 19LLA416 ; DYNJ0362304D , Lot Number 20BLA187 ; DYNJ0362304D , Lot Number 20CLA443 ; DYNJ0362304D , Lot Number 20CLA775 ; DYNJ0362304D , Lot Number 20DLA244 ; DYNJ0362304D , Lot Number 20ELA760 ; DYNJ0362304D , Lot Number 20FLA544 ; DYNJ0362304D , Lot Number 20GLA550 ; DYNJ0362304D , Lot Number 20HLA967 ; DYNJ0362304D , Lot Number 20JLA095 ; DYNJ0362304D , Lot Number 20JLA645 ; DYNJ0362304D , Lot Number 20LLA526 ; DYNJ0362304D , Lot Number 21ALA623 ; DYNJ0362304F, Lot Number 24BMH984; DYNJ0362304F, Lot Number 24BMB671; DYNJ0362304F , Lot Number 22CMI902 ; DYNJ0362304F , Lot Number 22GMD053 ; DYNJ0362304F , Lot Number 22HME894 ; DYNJ0362304F , Lot Number 22IMG325 ; DYNJ0362304F , Lot Number 23AMH833 ; DYNJ0362304F , Lot Number 23CMH913 ; DYNJ0362304F , Lot Number 23EMA109 ; DYNJ0362304F , Lot Number 23EMA575 ; DYNJ0362304F , Lot Number 23GMC5

Distribution pattern

Worldwide distribution.

device · product 19 of 81

Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number DYNJ17477G ; 6) ORAL SURGERY PACK-LF, Pack Number DYNJ20491N ; 7) DENTAL PACK-LF, Pack Number DYNJ36724C ; 8) DENTAL PACK WRM-LF, Pack Number DYNJ41963C ; 9) DENTAL SURGICOUNT , Pack Number DYNJ45540D ; 10) DENTAL PACK , Pack Number DYNJ49021F ; 11) DENTAL PACK , Pack Number DYNJ49021G ; 12) EXTRACTION PACK , Pack Number DYNJ49329F ; 13) CSC-N ORAL SURGERY PACK , Pack Number DYNJ50873B ; 14) ORAL SURGERY PACK , Pack Number DYNJ52404D ; 15) ORAL SURGERY PACK , Pack Number DYNJ52404F ; 16) ORAL SURGERY PACK , Pack Number DYNJ52404G ; 17) ORAL SURGERY PK RFID, Pack Number DYNJ52404I ; 18) WCMC PEDS DENTAL PACK , Pack Number DYNJ56307A ; 19) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157A ; 20) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157B ; 21) SURGERY KIT , Pack Number DYNJ58158A ; 22) SURGERY KIT , Pack Number DYNJ58158B ; 23) ORL PACK, Pack Number DYNJ59073B ; 24) ORAL SURGERY, Pack Number DYNJ59941B ; 25) ORAL SURGERY, Pack Number DYNJ59941BH; 26) MINOR DENTAL PACK-LF, Pack Number DYNJ61727I ; 27) MINOR DENTAL PACK-LF, Pack Number DYNJ61727J ; 28) MINOR DENTAL PACK-LF, Pack Number DYNJ61727K ; 29) MINOR DENTAL PACK-LF, Pack Number DYNJ61727L ; 30) DENTAL PACK , Pack Number DYNJ62779D ; 31) DENTAL PACK , Pack Number DYNJ62779F ; 32) DENTAL PACK , Pack Number DYNJ62779G ; 33) ORAL SURGERY PACK , Pack Number DYNJ66450B ; 34) ORAL PACK NTX , Pack Number DYNJ68506C ; 35) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226A ; 36) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226B ; 37) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226C ; 38) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226D ; 39) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226DH; 40) DENTAL PACK , Pack Number DYNJ80375; 41) ORAL SURGERY PACK , Pack Number DYNJ80619; 42) ORAL SURGERY PACK , Pack Number DYNJ80619A ; 43) DEAN DENTAL PACK, Pack Number DYNJ80644; 44) DEAN DENTAL PACK, Pack Number DYNJ80644A ; 45) DENTAL MINOR PACK , Pack Number DYNJ83140; 46) DENTAL PACK , Pack Number DYNJ84533; 47) ORAL SURGERY PACK-LF, Pack Number DYNJ84849; 48) ORAL, Pack Number DYNJ902377G; 49) ORAL SURGERY PACK-LF, Pack Number DYNJ904595D; 50) NYGH-MAJOR DENTAL-LF, Pack Number DYNJ905540F; 51) NYGH-MINOR DENTAL-PLASTIC-LF, Pack Number DYNJ905551C; 52) NORTH DENTAL, Pack Number DYNJ906941B; 53) ORAL, Pack Number DYNJ908371 ; 54) ORAL, Pack Number DYNJ908371A; 55) ORAL, Pack Number DYNJ908371B; 56) ORAL, Pack Number DYNJ908371C; 57) DENTAL, Pack Number DYNJ909635 ; 58) DENTAL, Pack Number DYNJ909635A

Z-2999-2024
Recall number
Z-2999-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS983010J ; Lot Number 22BBC009 ; CDS983010J ; Lot Number 22IBC611 ; CDS983010J ; Lot Number 22IBT150 ; CDS983010J ; Lot Number 22JBR866 ; CDS983010J ; Lot Number 23BBA121 ; CDS983010J ; Lot Number 23GBD710 ; CDS983010J ; Lot Number 23IBK805 ; CDS983010J ; Lot Number 23IBW114 ; CDS983010J ; Lot Number 23LMH952 ; DYNJ00354K ; Lot Number 23GMD230 ; DYNJ00354K ; Lot Number 23HMI535 ; DYNJ00354K ; Lot Number 23LMC320 ; DYNJ00354K ; Lot Number 23LMH116 ; DYNJ0426048L ; Lot Number 21FLA383 ; DYNJ0426048L ; Lot Number 21GLA406 ; DYNJ0426048L ; Lot Number 21GLB217 ; DYNJ0426048L ; Lot Number 21ILA230 ; DYNJ0426048L ; Lot Number 21JLA322 ; DYNJ0426048L ; Lot Number 21KLA413 ; DYNJ17477F ; Lot Number 22OBL759 ; DYNJ17477F ; Lot Number 22DBE452 ; DYNJ17477F ; Lot Number 22EBP359 ; DYNJ17477F ; Lot Number 22GBA339 ; DYNJ17477F ; Lot Number 22GBK261 ; DYNJ17477F ; Lot Number 22GBS374 ; DYNJ17477F ; Lot Number 22GBU600 ; DYNJ17477G ; Lot Number 22LBE020 ; DYNJ17477G ; Lot Number 23ABO736 ; DYNJ17477G ; Lot Number 23BBP921 ; DYNJ17477G ; Lot Number 23CBV133 ; DYNJ17477G ; Lot Number 23EBI573 ; DYNJ17477G ; Lot Number 23FBB745 ; DYNJ17477G ; Lot Number 23GBR631 ; DYNJ17477G ; Lot Number 23HBO131 ; DYNJ17477G ; Lot Number 23HBP963 ; DYNJ17477G ; Lot Number 23LBB041 ; DYNJ20491N ; Lot Number 21JDB764 ; DYNJ20491N ; Lot Number 21LDB850 ; DYNJ20491N ; Lot Number 22BDA344 ; DYNJ20491N ; Lot Number 22CDB501 ; DYNJ20491N ; Lot Number 22DDB894 ; DYNJ20491N ; Lot Number 22FDB186 ; DYNJ20491N ; Lot Number 22IDA002 ; DYNJ20491N ; Lot Number 22LDC230 ; DYNJ20491N ; Lot Number 23ADB460 ; DYNJ20491N ; Lot Number 23CDA315 ; DYNJ20491N ; Lot Number 23CDB899 ; DYNJ20491N ; Lot Number 23FDA431 ; DYNJ20491N ; Lot Number 23GDB331 ; DYNJ20491N ; Lot Number 23HDC417 ; DYNJ20491N ; Lot Number 23JDB061 ; DYNJ20491N ; Lot Number 23LDB174 ; DYNJ20491N ; Lot Number 24BDA747 ; DYNJ36724C ; Lot Number 22EBK043 ; DYNJ36724C ; Lot Number 22GBK775 ; DYNJ36724C ; Lot Number 22KBG650 ; DYNJ36724C ; Lot Number 22LBE175 ; 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DYNJ49329F ; Lot Number 22HBR730 ; DYNJ49329F ; Lot Number 22LBH164 ; DYNJ49329F ; Lot Number 22LBH169 ; DYNJ49329F ; Lot Number 22LBJ856 ; DYNJ49329F ; Lot Number 23GBH478 ; DYNJ49329F ; Lot Number 23GBS792 ; DYNJ49329F ; Lot Number 23HBJ404 ; DYNJ49329F ; Lot Number 23IBL117 ; DYNJ49329F ; Lot Number 23KBL247 ; DYNJ49329F ; Lot Number 23LBE302 ; DYNJ50873B ; Lot Number 22FMC506 ; DYNJ50873B ; Lot Number 23AMD590 ; DYNJ50873B ; Lot Number 23CMB861 ; DYNJ52404D ; Lot Number 21IDA311 ; DYNJ52404D ; Lot Number 21IDC346 ; DYNJ52404D ; Lot Number 21LDB538 ; DYNJ52404F ; Lot Number 22BDB993 ; DYNJ52404F ; Lot Number 22CDB805 ; DYNJ52404G ; Lot Number 22HDB737 ; DYNJ52404G ; Lot Number 22IDA539 ; DYNJ52404G ; Lot Number 22KDA882 ; DYNJ52404I ; Lot Number 23EDA538 ; DYNJ52404I ; Lot Number 23FDC351 ; DYNJ52404I ; Lot Number 23HDB384 ; DYNJ52404I ; Lot Number 23IDC338 ; DYNJ56307A ; Lot Number 23ABD150 ; DYNJ56307A ; Lot Number 23BBB625 ; DYNJ56307A ; Lot Number 23CBW951 ; DYNJ56307A ; Lot Number 23EBH936 ; DYNJ56307A ; Lot Number 23FBB061 ; DYNJ56307A ; Lot Number 23HBB009 ; DYNJ56307A ; Lot Number 23IBI467 ; DYNJ56307A ; Lot Number 23JBS836 ; DYNJ58157A ; Lot Number 21FME509 ; DYNJ58157A ; Lot Number 21IMF607 ; DYNJ58157A ; Lot Number 21JMG595 ; DYNJ58157B ; Lot Number 21LMC008 ; DYNJ58157B ; Lot Number 22AME233 ; DYNJ58157B ; Lot Number 22CMI562 ; DYNJ58157B ; Lot Number 22HMF125 ; DYNJ58157B ; Lot Number 23AMH028 ; DYNJ58157B ; Lot Number 23DMA886 ; DYNJ58157B ; Lot Number 23EMH308 ; DYNJ58157B ; Lot Number 23JMB317 ; DYNJ58157B ; Lot Number 23JMJ548 ; DYNJ58157B ; Lot Number 23KMJ285 ; DYNJ58158A ; Lot Number 21LMG842 ; DYNJ58158A ; Lot Number 22EMC770 ; DYNJ58158A ; Lot Number 22FMB369 ; DYNJ58158A ; Lot Number 22FMH686 ; DYNJ58158A ; Lot Number 22HMC012 ; DYNJ58158A ; Lot Number 22HMF727 ; DYNJ58158B ; Lot Number 22IMG255 ; DYNJ58158B ; Lot Number 22LMI669 ; DYNJ58158B ; Lot Number 22LMI675 ; DYNJ58158B ; Lot Number 23CMC282 ; DYNJ58158B ; Lot Number 23EMA456 ; DYNJ58158B ; Lot Number 23FMH442 ; DYNJ58158B ; Lot Number 23GMC744 ; DYNJ58158B ; Lot Number 23HMB209 ; DYNJ58158B ; Lot Number 23KMB074 ; DYNJ58158B ; Lot Number 23LMB171 ; DYNJ59073B ; Lot Number 22IBK839 ; DYNJ59073B ; Lot Number 22JBI913 ; DYNJ59073B ; Lot Number 22KBK454 ; DYNJ59073B ; Lot Number 22LBQ309 ; DYNJ59073B ; Lot Number 23BBA464 ; DYNJ59073B ; Lot Number 23CBG401 ; DYNJ59073B ; Lot Number 23CBU743 ; DYNJ59073B ; Lot Number 23EBL522 ; DYNJ59073B ; Lot Number 23GBE642 ; DYNJ59073B ; Lot Number 23GBU324 ; DYNJ59073B ; Lot Number 23HBA871 ; DYNJ59073B ; Lot Number 23IBA626 ; DYNJ59073B ; Lot Number 23IBS781 ; DYNJ59073B ; Lot Number 23KBL505 ; DYNJ59941B ; Lot Number 21LBF565 ; DYNJ59941B ; Lot Number 22ABU134 ; DYNJ59941B ; Lot Number 22BBH754 ; DYNJ59941B ; Lot Number 22FBU080 ; DYNJ59941B ; Lot Number 22IBG644 ; DYNJ59941B ; Lot Number 22JBG893 ; DYNJ59941B ; Lot Number 22JBQ925 ; DYNJ59941B ; Lot Number 22KBL124 ; DYNJ59941B ; Lot Number 23ABD993 ; DYNJ59941B ; Lot Number 23BBA808 ; DYNJ59941B ; Lot Number 23CBM134 ; DYNJ59941B ; Lot Number 23FBV200 ; DYNJ59941B ; Lot Number 23HBJ311 ; DYNJ59941B ; Lot Number 23JBC693 ; DYNJ59941B ; Lot Number 23KBT719 ; DYNJ59941B ; Lot Number 24ABA734 ; DYNJ59941BH; Lot Number 21LBF565 ; DYNJ59941BH; Lot Number 22ABU134 ; DYNJ59941BH; Lot Number 22BBH754 ; DYNJ59941BH; Lot Number 22FBU080 ; DYNJ59941BH; Lot Number 22IBG644 ; DYNJ59941BH; Lot Number 22JBG893 ; DYNJ59941BH; Lot Number 22JBQ925 ; DYNJ59941BH; Lot Number 22KBL124 ; DYNJ59941BH; Lot Number 23ABD993 ; DYNJ59941BH; Lot Number 23BBA808 ; DYNJ59941BH; Lot Number 23CBM134 ; DYNJ59941BH; Lot Number 23FBV200 ; DYNJ59941BH; Lot Number 23HBJ311 ; DYNJ59941BH; Lot Number 23JBC693 ; DYNJ59941BH; Lot Number 23KBT719 ; DYNJ59941BH; Lot Number 24ABA734 ; DYNJ61727I ; Lot Number 21JBK294 ; DYNJ61727J ; Lot Number 21LBD388 ; DYNJ61727J ; Lot Number 22BBN014 ; DYNJ61727J ; Lot Number 22CBF193 ; DYNJ61727J ; Lot Number 22CMG015 ; DYNJ61727J ; Lot Number 22EMI228 ; DYNJ61727J ; Lot Number 22FMB017 ; DYNJ61727J ; Lot Number 22FME781 ; DYNJ61727J ; Lot Number 22GMG733 ; DYNJ61727J ; Lot Number 22HMF449 ; DYNJ61727K ; Lot Number 22JMI349 ; DYNJ61727K ; Lot Number 23AMC095 ; DYNJ61727K ; Lot Number 23CMD238 ; DYNJ61727K ; Lot Number 23DMF668 ; DYNJ61727K ; Lot Number 23EME231 ; DYNJ61727K ; Lot Number 23EMH529 ; DYNJ61727K ; Lot Number 23FMB563 ; DYNJ61727K ; Lot Number 23GMC405 ; DYNJ61727L ; Lot Number 23IMF670 ; DYNJ61727L ; Lot Number 23IMI141 ; DYNJ61727L ; Lot Number 23JMI361 ; DYNJ61727L ; Lot Number 23KMA126 ; DYNJ61727L ; Lot Number 23LMB824 ; DYNJ62779D ; Lot Number 22EDA032 ; DYNJ62779D ; Lot Number 22EDA489 ; DYNJ62779F ; Lot Number 22HDA403 ; DYNJ62779G ; Lot Number 23GDA168 ; DYNJ62779G ; Lot Number 23GDB451 ; DYNJ66450B ; Lot Number 22IBB948 ; DYNJ66450B ; Lot Number 22KBV773 ; DYNJ66450B ; Lot Number 23EBR729 ; DYNJ66450B ; Lot Number 23JBW720 ; DYNJ66450B ; Lot Number 23LBH114 ; DYNJ68506C ; Lot Number 23DBS664 ; DYNJ68506C ; Lot Number 23DBS853 ; DYNJ68506C ; Lot Number 23FBG056 ; DYNJ68506C ; Lot Number 23GBM557 ; DYNJ68506C ; Lot Number 23HBN011 ; DYNJ68506C ; Lot Number 23JBM846 ; DYNJ68506C ; Lot Number 23LBC658 ; DYNJ80226A ; Lot Number 22FBV173 ; DYNJ80226A ; Lot Number 22FBV174 ; DYNJ80226A ; Lot Number 22GBV225 ; DYNJ80226B ; Lot Number 22HBC718 ; DYNJ80226B ; Lot Number 22IBU418 ; DYNJ80226B ; Lot Number 22JBI169 ; DYNJ80226B ; Lot Number 22LBD065 ; DYNJ80226C ; Lot Number 23ABG109 ; DYNJ80226C ; Lot Number 23BBS329 ; DYNJ80226C ; Lot Number 23EBD031 ; DYNJ80226D ; Lot Number 23FBQ147 ; DYNJ80226D ; Lot Number 23GBI193 ; DYNJ80226D ; Lot Number 23HBD258 ; DYNJ80226D ; Lot Number 23HBR280 ; DYNJ80226D ; Lot Number 23KBT438 ; DYNJ80226D ; Lot Number 24ABD298 ; DYNJ80226D ; Lot Number 24ABU028 ; DYNJ80226DH; Lot Number 23FBQ147 ; DYNJ80226DH; Lot Number 23GBI193 ; DYNJ80226DH; Lot Number 23HBD258 ; DYNJ80226DH; Lot Number 23HBR280 ; DYNJ80226DH; Lot Number 23KBT438 ; DYNJ80226DH; Lot Number 24ABD298 ; DYNJ80226DH; Lot Number 24ABU028 ; DYNJ80375; Lot Number 22CBG092 ; DYNJ80375; Lot Number 22EBQ917 ; DYNJ80375; Lot Number 22IBQ585 ; DYNJ80375; Lot Number 23FBS558 ; DYNJ80375; Lot Number 23HBJ402 ; DYNJ80619; Lot Number 22BMA820 ; DYNJ80619; Lot Number 22DMH324 ; DYNJ80619; Lot Number 22FMD997 ; DYNJ80619A ; Lot Number 22IME438 ; DYNJ80619A ; Lot Number 22KMC350 ; DYNJ80619A ; Lot Number 22LMB169 ; DYNJ80619A ; Lot Number 23BMB182 ; DYNJ80619A ; Lot Number 23BMH351 ; DYNJ80619A ; Lot Number 23DME515 ; DYNJ80619A ; Lot Number 23EMI879 ; DYNJ80644; Lot Number 22BDB904 ; DYNJ80644; Lot Number 22DDB750 ; DYNJ80644; Lot Number 23GDA137 ; DYNJ80644; Lot Number 23GDB599 ; DYNJ80644; Lot Number 23KDB158 ; DYNJ80644A ; Lot Number 23KDC248 ; DYNJ80644A ; Lot Number 24ADB620 ; DYNJ83140; Lot Number 22JBN386 ; DYNJ84533; Lot Number 23FBJ203 ; DYNJ84533; Lot Number 23HBI888 ; DYNJ84849; Lot Number 23HBQ884 ; DYNJ902377G; Lot Number 22JBA943 ; DYNJ902377G; Lot Number 22JBO834 ; DYNJ902377G; Lot Number 22KBG529 ; DYNJ902377G; Lot Number 22KBK524 ; DYNJ902377G; Lot Number 23ABC461 ; DYNJ902377G; Lot Number 23BBN939 ; DYNJ902377G; Lot Number 23EBN577 ; DYNJ904595D; Lot Number 22FBX893 ; DYNJ904595D; Lot Number 22GBX101 ; DYNJ904595D; Lot Number 22GBX102 ; DYNJ904595D; Lot Number 22GBX452 ; DYNJ904595D; Lot Number 23BBG733 ; DYNJ904595D; Lot Number 23BBU681 ; DYNJ904595D; Lot Number 23CBM716 ; DYNJ904595D; Lot Number 23CBO282 ; DYNJ904595D; Lot Number 23CBR749 ; DYNJ904595D; Lot Number 23CBT365 ; DYNJ905540F; Lot Number 23LBU879 ; DYNJ905540F; Lot Number 24ABP739 ; DYNJ905551C; Lot Number 23LBF673 ; DYNJ905551C; Lot Number 24ABB211 ; DYNJ905551C; Lot Number 24CBA921 ; DYNJ905551C; Lot Number 24CBJ238 ; DYNJ906941B; Lot Number 22FBM740 ; DYNJ906941B; Lot Number 22GBT635 ; DYNJ906941B; Lot Number 22KBO727 ; DYNJ906941B; Lot Number 23ABC523 ; DYNJ906941B; Lot Number 23ABQ444 ; DYNJ906941B; Lot Number 23EBL207 ; DYNJ906941B; Lot Number 23HBM842 ; DYNJ906941B; Lot Number 23JBD314 ; DYNJ906941B; Lot Number 23KBB990 ; DYNJ906941B; Lot Number 24ABE237 ; DYNJ906941B; Lot Number 24ABP612 ; DYNJ906941B; Lot Number 22BDB731 ; DYNJ906941B; Lot Number 22DDA710 ; DYNJ908371 ; Lot Number 22ALA451 ; DYNJ908371 ; Lot Number 22BLA143 ; DYNJ908371 ; Lot Number 22BLA457 ; DYNJ908371 ; Lot Number 22ELA506 ; DYNJ908371 ; Lot Number 22FLB139 ; DYNJ908371 ; Lot Number 22ILA735 ; DYNJ908371 ; Lot Number 22JLA042 ; DYNJ908371 ; Lot Number 22JLA376 ; DYNJ908371 ; Lot Number 22JLB047 ; DYNJ908371 ; Lot Number 22LLA214 ; DYNJ908371A; Lot Number 23BLA843 ; DYNJ908371A; Lot Number 23DLA646 ; DYNJ908371B; Lot Number 23GLA546 ; DYNJ908371B; Lot Number 23ILA755 ; DYNJ908371B; Lot Number 23JLB151 ; DYNJ908371B; Lot Number 23KLB029 ; DYNJ908371B; Lot Number 23LLB017 ; DYNJ908371C; Lot Number 24BLA656 ; DYNJ909635 ; Lot Number 23FBI195 ; DYNJ909635A; Lot Number 23IBA327 ; DYNJ909635A; Lot Number 23KBT027

Distribution pattern

Worldwide distribution.

device · product 20 of 81

Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C

Z-3000-2024
Recall number
Z-3000-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ43427C , Lot Number 21HBA933 ; DYNJ43427C , Lot Number 22ABL557 ; DYNJ43427C , Lot Number 22BBL591 ; DYNJ43427C , Lot Number 19ABE939 ; DYNJ43427C , Lot Number 19ABM274 ; DYNJ43427C , Lot Number 19ABT846 ; DYNJ43427C , Lot Number 22DBL373 ; DYNJ43427C , Lot Number 22FBV273 ; DYNJ43427C , Lot Number 22GBE783 ; DYNJ43427C , Lot Number 22HBY245 ; DYNJ43427C , Lot Number 22IBS212 ; DYNJ43427C , Lot Number 19IBD112 ; DYNJ43427C , Lot Number 22KBT930 ; DYNJ43427C , Lot Number 22KBV623 ; DYNJ43427C , Lot Number 19JBZ344 ; DYNJ43427C , Lot Number 23ABM258 ; DYNJ43427C , Lot Number 23CBQ295 ; DYNJ43427C , Lot Number 23DBQ887 ; DYNJ43427C , Lot Number 23EBQ116 ; DYNJ43427C , Lot Number 20BBH601 ; DYNJ43427C , Lot Number 23GBI661 ; DYNJ43427C , Lot Number 20DBE542 ; DYNJ43427C , Lot Number 23HBQ003 ; DYNJ43427C , Lot Number 20EBM157 ; DYNJ43427C , Lot Number 23JBX153 ; DYNJ43427C , Lot Number 20GBU737 ; DYNJ43427C , Lot Number 20HBR283 ; DYNJ43427C , Lot Number 23LBR867 ; DYNJ43427C , Lot Number 20IBB669 ; DYNJ43427C , Lot Number 20IBK144

Distribution pattern

Worldwide distribution.

device · product 21 of 81

Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ; 6) RHINOPLASTY PACK, Pack Number DYNJ27333F ; 7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ; 8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ; 9) RHINO PACK, Pack Number DYNJ46504A ; 10) RHINO PACK, Pack Number DYNJ46504B ; 11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ; 12) PACEMAKER PACK, Pack Number DYNJ49787A ; 13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ; 14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ; 15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ; 16) SEPTO RHINO PACK, Pack Number DYNJ53076C ; 17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ; 18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ; 19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ; 20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ; 21) NOSE ESC, Pack Number DYNJ62371A ; 22) NASAL PACK, Pack Number DYNJ67789A ; 23) LOU MAJOR ENT , Pack Number DYNJ901851D; 24) LOU MINOR ENT , Pack Number DYNJ901852C; 25) RHYZOTOMY , Pack Number DYNJ902288G; 26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501

Z-3001-2024
Recall number
Z-3001-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS983173G , Lot Number 21FBQ527 ; CDS983173G , Lot Number 21HBF657 ; CDS983173G , Lot Number 21IBE910 ; CDS983173G , Lot Number 21IBM809 ; CDS983173G , Lot Number 21JBJ185 ; CDS983173G , Lot Number 21KBM498 ; CDS983173G , Lot Number 22ABF773 ; CDS983173G , Lot Number 22BBH011 ; CDS983173G , Lot Number 19ABX210 ; CDS983173G , Lot Number 22OBM500 ; CDS983173G , Lot Number 22EBQ566 ; CDS983173G , Lot Number 19GBS147 ; CDS983173G , Lot Number 19IBG146 ; CDS983173G , Lot Number 19IBJ785 ; CDS983173G , Lot Number 19KBA219 ; CDS983173G , Lot Number 19KBA926 ; CDS983173G , Lot Number 20BBA113 ; CDS983173G , Lot Number 20CBP609 ; CDS983173G , Lot Number 20DBU576 ; CDS983173G , Lot Number 20HBQ718 ; CDS983173G , Lot Number 20KBY137 ; CDS983173G , Lot Number 20LBL243 ; CDS983173G , Lot Number 21BBO662 ; CDS983173G , Lot Number 21EBC912 ; CDS983181D , Lot Number 21FBP606 ; CDS983181D , Lot Number 21FBP608 ; CDS983181D , Lot Number 21GBM695 ; CDS983181D , Lot Number 21IBW768 ; CDS983181D , Lot Number 21KBT227 ; CDS983181D , Lot Number 21KBT228 ; CDS983181D , Lot Number 22ABD357 ; CDS983181D , Lot Number 19ABU206 ; CDS983181D , Lot Number 19BBQ372 ; CDS983181D , Lot Number 19CBK097 ; CDS983181D , Lot Number 22OBL824 ; CDS983181D , Lot Number 19QBA591 ; CDS983181D , Lot Number 19FBV743 ; CDS983181D , Lot Number 19IBF802 ; CDS983181D , Lot Number 19KBD950 ; CDS983181D , Lot Number 19LBK648 ; CDS983181D , Lot Number 20ABR683 ; CDS983181D , Lot Number 20BBA165 ; CDS983181D , Lot Number 20FBI684 ; CDS983181D , Lot Number 20FBR746 ; CDS983181D , Lot Number 20GBU594 ; CDS983181D , Lot Number 20IBE821 ; CDS983181D , Lot Number 20KBH269 ; CDS983181D , Lot Number 20WBC647 ; CDS983181D , Lot Number 20LBM653 ; CDS983181D , Lot Number 21CBT353 ; DYNJ0664747A , Lot Number 18LKD127 ; DYNJ0664747A , Lot Number 19BKB344 ; DYNJ0664747A , Lot Number 19CKC913 ; DYNJ0664747A , Lot Number 19EKC333 ; DYNJ0664747A , Lot Number 19FKC411 ; DYNJ0664747A , Lot Number 19GKC274 ; DYNJ0664747A , Lot Number 19HKB760 ; DYNJ0664747A , Lot Number 19JKA880 ; DYNJ0664747A , Lot Number 19LKB543 ; DYNJ0664747A , Lot Number 20CKB577 ; DYNJ0664747A , Lot Number 20FKB280 ; DYNJ0796243D , Lot Number 19DBI829 ; DYNJ0796243D , Lot Number 19FBR591 ; DYNJ0796243D , Lot Number 19SBB284 ; DYNJ0796243D , Lot Number 20ABR331 ; DYNJ0796243D , Lot Number 20CBD369 ; DYNJ0796243F , Lot Number 20DBS625 ; DYNJ0796243F , Lot Number 20EBL722 ; DYNJ0796243F , Lot Number 20IBA666 ; DYNJ27333F , Lot Number 19BBO791 ; DYNJ27333F , Lot Number 19DBP940 ; DYNJ27333F , Lot Number 19FBE534 ; DYNJ27333F , Lot Number 19GBR210 ; DYNJ27333F , Lot Number 19IBE745 ; DYNJ27333F , Lot Number 19JBS092 ; DYNJ27333F , Lot Number 19LBW235 ; DYNJ27333F , Lot Number 20ABI785 ; DYNJ27333F , Lot Number 23IBA132 ; DYNJ27333F , Lot Number 23IBM081 ; DYNJ27333F , Lot Number 20GMB327 ; DYNJ27333F , Lot Number 20HMC020 ; DYNJ27333F , Lot Number 20JMB190 ; DYNJ27333F , Lot Number 21BMA104 ; DYNJ27333F , Lot Number 21CMC745 ; DYNJ27333F , Lot Number 21EMA918 ; DYNJ27333F , Lot Number 21EMF099 ; DYNJ27333F , Lot Number 21GME154 ; DYNJ27333F , Lot Number 21IMD341 ; DYNJ27333F , Lot Number 21JMG293 ; DYNJ27333F , Lot Number 21KMH297 ; DYNJ27333F , Lot Number 22AMB529 ; DYNJ27333F , Lot Number 22AME230 ; DYNJ27333F , Lot Number 22CMA564 ; DYNJ27333F , Lot Number 22EMC594 ; DYNJ27333F , Lot Number 22JMD960 ; DYNJ27333F , Lot Number 22LMA318 ; DYNJ27333F , Lot Number 23BMI006 ; DYNJ27333F , Lot Number 23DMF413 ; DYNJ27333F , Lot Number 23EMI496 ; DYNJ27333F , Lot Number 23FMF200 ; DYNJ37384C , Lot Number 19ABU440 ; DYNJ37384C , Lot Number 19CBU785 ; DYNJ37384C , Lot Number 19FBL799 ; DYNJ37384C , Lot Number 19GBW911 ; DYNJ37384C , Lot Number 19IBA811 ; DYNJ37384C , Lot Number 19JBH727 ; DYNJ37384C , Lot Number 19KBT009 ; DYNJ37384C , Lot Number 19LBS039 ; DYNJ37384D , Lot Number 21GBK114 ; DYNJ37384D , Lot Number 21IBR322 ; DYNJ37384D , Lot Number 21KBG185 ; DYNJ37384D , Lot Number 21LBO506 ; DYNJ37384D , Lot Number 22FBJ098 ; DYNJ37384D , Lot Number 22HBY172 ; DYNJ37384D , Lot Number 22KBR101 ; DYNJ37384D , Lot Number 23EBC350 ; DYNJ37384D , Lot Number 20CBZ636 ; DYNJ37384D , Lot Number 20EBS338 ; DYNJ37384D , Lot Number 20FBK766 ; DYNJ37384D , Lot Number 23JBO321 ; DYNJ37384D , Lot Number 20HBB525 ; DYNJ37384D , Lot Number 23LBL338 ; DYNJ37384D , Lot Number 20IBJ892 ; DYNJ37384D , Lot Number 21ABE659 ; DYNJ37384D , Lot Number 21CBJ121 ; DYNJ46504A , Lot Number 19BDB160 ; DYNJ46504A , Lot Number 19DDB252 ; DYNJ46504A , Lot Number 19EDC611 ; DYNJ46504B , Lot Number 19JDA999 ; DYNJ46504B , Lot Number 20BMB648 ; DYNJ46504B , Lot Number 20DMB154 ; DYNJ46504B , Lot Number 20HMB453 ; DYNJ46504B , Lot Number 20KMB679 ; DYNJ46504B , Lot Number 21BMB155 ; DYNJ46504B , Lot Number 21CMB708 ; DYNJ46504B , Lot Number 21EMB698 ; DYNJ46504B , Lot Number 21GMD919 ; DYNJ46504B , Lot Number 21IME243 ; DYNJ46741B , Lot Number 21IBG995 ; DYNJ46741B , Lot Number 21IBG997 ; DYNJ46741B , Lot Number 22BBT724 ; DYNJ46741B , Lot Number 19CBB765 ; DYNJ46741B , Lot Number 22EBP222 ; DYNJ46741B , Lot Number 19FBK777 ; DYNJ46741B , Lot Number 19VBA126 ; DYNJ46741B , Lot Number 19KBL310 ; DYNJ46741B , Lot Number 19KBN384 ; DYNJ46741B , Lot Number 23HBN994 ; DYNJ46741B , Lot Number 23HBP810 ; DYNJ49787A , Lot Number 21FBN016 ; DYNJ49787A , Lot Number 21GBM408 ; DYNJ49787A , Lot Number 21GBM428 ; DYNJ49787A , Lot Number 22ABM108 ; DYNJ49787A , Lot Number 19ABN326 ; DYNJ49787A , Lot Number 19CBP767 ; DYNJ49787A , Lot Number 19CBQ107 ; DYNJ49787A , Lot Number 22DBM828 ; DYNJ49787A , Lot Number 22EBG252 ; DYNJ49787A , Lot Number 22IBJ471 ; DYNJ49787A , Lot Number 19HBY419 ; DYNJ49787A , Lot Number 19IBT824 ; DYNJ49787A , Lot Number 19JBW889 ; DYNJ49787A , Lot Number 19KBE624 ; DYNJ49787A , Lot Number 23BBA335 ; DYNJ49787A , Lot Number 23BBA675 ; DYNJ49787A , Lot Number 19LBW938 ; DYNJ49787A , Lot Number 23EBH476 ; DYNJ49787A , Lot Number 20DBR037 ; DYNJ49787A , Lot Number 23HBP202 ; DYNJ49787A , Lot Number 23IBS466 ; DYNJ49787A , Lot Number 20FBC511 ; DYNJ49787A , Lot Number 20GBS300 ; DYNJ49787A , Lot Number 20HBM368 ; DYNJ49787A , Lot Number 20HBS801 ; DYNJ49787A , Lot Number 20IBN275 ; DYNJ49787A , Lot Number 21BBF686 ; DYNJ49787A , Lot Number 21OBA269 ; DYNJ50425A , Lot Number 21HBA360 ; DYNJ50425A , Lot Number 21IBQ864 ; DYNJ50425A , Lot Number 19BBQ595 ; DYNJ50425A , Lot Number 19EBY242 ; DYNJ50425A , Lot Number 19FBI087 ; DYNJ50425A , Lot Number 20BBE774 ; DYNJ50425A , Lot Number 20EBK250 ; DYNJ50425A , Lot Number 20JBC222 ; DYNJ50425A , Lot Number 20WBD637 ; DYNJ50425A , Lot Number 21ABT114 ; DYNJ51677A , Lot Number 19BDA361 ; DYNJ51677A , Lot Number 19DDC824 ; DYNJ51677A , Lot Number 19GDB503 ; DYNJ51677A , Lot Number 19HDB601 ; DYNJ51677B , Lot Number 19LDB205 ; DYNJ51677B , Lot Number 20ADA661 ; DYNJ51677B , Lot Number 20BDC766 ; DYNJ51677B , Lot Number 20FDA983 ; DYNJ51677B , Lot Number 21DDB294 ; DYNJ51677B , Lot Number 21DDB913 ; DYNJ51677B , Lot Number 21IDA884 ; DYNJ51677B , Lot Number 21KDB891 ; DYNJ51677B , Lot Number 22BDB470 ; DYNJ51677B , Lot Number 22FDA247 ; DYNJ53076C , Lot Number 19ABB038 ; DYNJ53076C , Lot Number 19DBB639 ; DYNJ53076C , Lot Number 19IBM131 ; DYNJ54901A , Lot Number 20FMB225 ; DYNJ54901A , Lot Number 20GMB646 ; DYNJ54901A , Lot Number 19CKB852 ; DYNJ54901A , Lot Number 19CKD589 ; DYNJ54901A , Lot Number 19GKA497 ; DYNJ54901A , Lot Number 19HKA603 ; DYNJ54901A , Lot Number 19IKA618 ; DYNJ54901A , Lot Number 19JKA239 ; DYNJ54901A , Lot Number 19KKA565 ; DYNJ54901A , Lot Number 20AKB491 ; DYNJ55955B , Lot Number 20GBI567 ; DYNJ55955C , Lot Number 20IBM103 ; DYNJ55955C , Lot Number 20JBO651 ; DYNJ55955C , Lot Number 20KBZ444 ; DYNJ55955C , Lot Number 21ABF008 ; DYNJ55955C , Lot Number 21OBA488 ; DYNJ55955C , Lot Number 21DBP964 ; DYNJ55955C , Lot Number 21EBN493 ; DYNJ55955C , Lot Number 21FBB400 ; DYNJ60872B , Lot Number 21HBG657 ; DYNJ60872B , Lot Number 22GBF268 ; DYNJ60872B , Lot Number 23JBX988 ; DYNJ60872B , Lot Number 21FBG560 ; DYNJ62371A , Lot Number 19HBX688 ; DYNJ62371A , Lot Number 19JBX716 ; DYNJ62371A , Lot Number 19KBZ297 ; DYNJ62371A , Lot Number 19LBW815 ; DYNJ62371A , Lot Number 20CBL259 ; DYNJ62371A , Lot Number 20CBT802 ; DYNJ62371A , Lot Number 20GBA607 ; DYNJ67789A , Lot Number 21GBW066 ; DYNJ67789A , Lot Number 21JBK474 ; DYNJ67789A , Lot Number 21KBS434 ; DYNJ67789A , Lot Number 21KBX401 ; DYNJ67789A , Lot Number 22OBB247 ; DYNJ67789A , Lot Number 22FBW392 ; DYNJ67789A , Lot Number 23BBB609 ; DYNJ67789A , Lot Number 23EBD035 ; DYNJ67789A , Lot Number 23FBJ867 ; DYNJ67789A , Lot Number 23GBS485 ; DYNJ67789A , Lot Number 23KBP837 ; DYNJ901851D, Lot Number 21HBJ140 ; DYNJ901851D, Lot Number 22BBU915 ; DYNJ901851D, Lot Number 22CBC697 ; DYNJ901851D, Lot Number 22DBK808 ; DYNJ901851D, Lot Number 22FBB271 ; DYNJ901851D, Lot Number 22GBT167 ; DYNJ901851D, Lot Number 22HBI855 ; DYNJ901851D, Lot Number 22HBS216 ; DYNJ901851D, Lot Number 22IBK656 ; DYNJ901851D, Lot Number 20XBC489 ; DYNJ901851D, Lot Number 21BBN648 ; DYNJ901851D, Lot Number 21DBL095 ; DYNJ901852C, Lot Number 21HBF301 ; DYNJ901852C, Lot Number 21JBJ762 ; DYNJ901852C, Lot Number 22NBF331 ; DYNJ901852C, Lot Number 22HBA397 ; DYNJ901852C, Lot Number 22HBS590 ; DYNJ901852C, Lot Number 22IBJ339 ; DYNJ901852C, Lot Number 22IBK137 ; DYNJ901852C, Lot Number 22JBQ953 ; DYNJ901852C, Lot Number 23CBO466 ; DYNJ901852C, Lot Number 20JBP459 ; DYNJ901852C, Lot Number 20KBU993 ; DYNJ901852C, Lot Number 20LBI528 ; DYNJ902288G, Lot Number 21HBF299 ; DYNJ902288G, Lot Number 21KBE091 ; DYNJ902288G, Lot Number 22BBV084 ; DYNJ902288G, Lot Number 22CBU916 ; DYNJ902288G, Lot Number 22GBF564 ; DYNJ902288G, Lot Number 22HBR861 ; DYNJ902288G, Lot Number 22JBT657 ; DYNJ902288G, Lot Number 22JBU356 ; DYNJ902288G, Lot Number 22LBE926 ; DYNJ902288G, Lot Number 23ABP445 ; DYNJ902288G, Lot Number 23EBV643 ; DYNJCH501, Lot Number 21KBY680 ; DYNJCH501, Lot Number 22ABM471 ; DYNJCH501, Lot Number 22BBL916 ; DYNJCH501, Lot Number 19ABD074 ; DYNJCH501, Lot Number 19CBB360 ; DYNJCH501, Lot Number 22DBF067 ; DYNJCH501, Lot Number 19DBR849 ; DYNJCH501, Lot Number 22EBV599 ; DYNJCH501, Lot Number 22FBL881 ; DYNJCH501, Lot Number 19FBN752 ; DYNJCH501, Lot Number 22HBM496 ; DYNJCH501, Lot Number 19HBN083 ; DYNJCH501, Lot Number 19HBU577 ; DYNJCH501, Lot Number 22KBV428 ; DYNJCH501, Lot Number 19VBE030 ; DYNJCH501, Lot Number 23CBN141 ; DYNJCH501, Lot Number 19LBX198 ; DYNJCH501, Lot Number 23EBI679 ; DYNJCH501, Lot Number 20BBO413 ; DYNJCH501, Lot Number 23FBU553 ; DYNJCH501, Lot Number 23GBW146 ; DYNJCH501, Lot Number 20DBG592 ; DYNJCH501, Lot Number 20GBD248 ; DYNJCH501, Lot Number 23KBG555 ; DYNJCH501, Lot Number 23KBQ114 ; DYNJCH501, Lot Number 20IBS257 ; DYNJCH501, Lot Number 21ABA600 ; DYNJCH501, Lot Number 21BBO693 ; DYNJCH501, Lot Number 21EBB740

Distribution pattern

Worldwide distribution.

device · product 22 of 81

Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ; 6) CAROTID CDS-LF, Pack Number CDS840056N ; 7) CAROTID-LF, Pack Number CDS860039J ; 8) T & A PROCEDURE-LF, Pack Number CDS860047X ; 9) THORACOTOMY CDS , Pack Number CDS920065R ; 10) EAR CDS , Pack Number CDS980089L ; 11) EAR CDS , Pack Number CDS980089M ; 12) EAR CDS , Pack Number CDS980089N ; 13) EAR CDS , Pack Number CDS980089O ; 14) ENDOSCOPY , Pack Number CDS980201R ; 15) TYMPANOPLASTY , Pack Number CDS980203R ; 16) TYMPANOPLASTY , Pack Number CDS980203S ; 17) TYMPANO CDS , Pack Number CDS980374M ; 18) TYMPANO CDS , Pack Number CDS980374O ; 19) TYMPANO CDS , Pack Number CDS980374P ; 20) THORACOTOMY CDS , Pack Number CDS980446T ; 21) SINUS CDS , Pack Number CDS980579D ; 22) EENT-HEAD AND NECK, Pack Number CDS980809K ; 23) EENT-HEAD AND NECK, Pack Number CDS980809L ; 24) EENT-HEAD AND NECK, Pack Number CDS980809M ; 25) FESS PROCEDURE, Pack Number CDS981185B ; 26) CDS981571P, Pack Number CDS981571P ; 27) SINUS CDS-LF, Pack Number CDS981692J ; 28) EAR CDS , Pack Number CDS981985F ; 29) MAJOR EAR , Pack Number CDS982016Q ; 30) MAJOR EAR , Pack Number CDS982016R ; 31) MAJOR EAR , Pack Number CDS982016S ; 32) MAJOR EAR , Pack Number CDS982016T ; 33) SINUS , Pack Number CDS982020O ; 34) SINUS , Pack Number CDS982020P ; 35) SINUS , Pack Number CDS982020R ; 36) NASAL/SEPTAL, Pack Number CDS982049M; 37) NASAL/SEPTAL, Pack Number CDS982049O; 38) T&A CDS-LF, Pack Number CDS982091I ; 39) EAR-EENT CDS, Pack Number CDS982307F ; 40) EAR-EENT CDS, Pack Number CDS982307G ; 41) EAR-EENT CDS, Pack Number CDS982307J ; 42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ; 43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ; 44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ; 45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ; 46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ; 47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ; 48) EAR CDS-LF, Pack Number CDS982612B ; 49) T AND A CDS MRH , Pack Number CDS982622L ; 50) CAROTID , Pack Number CDS982638J ; 51) NASAL CDS , Pack Number CDS982655C ; 52) NASAL CDS , Pack Number CDS982655D ; 53) NASAL CDS , Pack Number CDS982655F ; 54) NECK THYROID, Pack Number CDS982692M ; 55) NECK THYROID, Pack Number CDS982692N ; 56) NECK THYROID, Pack Number CDS982692O ; 57) TYMPANOPLASTY , Pack Number CDS982720N ; 58) TYMPANOPLASTY , Pack Number CDS982720P ; 59) TYMPANOPLASTY , Pack Number CDS982720Q ; 60) TYMPANOPLASTY , Pack Number CDS982720R ; 61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ; 62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ; 63) SINUS CDS-1 , Pack Number CDS982901F ; 64) MIDDLE EAR CDS, Pack Number CDS982938J ; 65) MIDDLE EAR CDS, Pack Number CDS982938K ; 66) MIDDLE EAR CDS, Pack Number CDS982938L ; 67) MIDDLE EAR CDS, Pack Number CDS982938O ; 68) SMR/RHINO CDS , Pack Number CDS982939L ; 69) SMR/RHINO CDS , Pack Number CDS982939M ; 70) SMR/RHINO CDS , Pack Number CDS982939N ; 71) SMR/RHINO CDS , Pack Number CDS982939Q ; 72) SMR/RHINO CDS , Pack Number CDS982939R ; 73) SMR/RHINO CDS , Pack Number CDS982939S ; 74) T&A CDS , Pack Number CDS982944J ; 75) T&A CDS , Pack Number CDS982944K ; 76) MINOR EAR , Pack Number CDS982989K ; 77) MINOR EAR , Pack Number CDS982989L ; 78) MINOR EAR , Pack Number CDS982989M ; 79) MINOR EAR , Pack Number CDS982989N ; 80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ; 81) ENT CDS , Pack Number CDS983035J ; 82) ENT CDS , Pack Number CDS983035L ; 83) ENT CDS , Pack Number CDS983035M ; 84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ; 85) CHP TYMPMASTOID CDS, Pack Number CDS983088J; 86) HEAD & NECK CDS , Pack Number CDS983126B ; 87) HEAD & NECK CDS , Pack Number CDS983126C ; 88) CAROTID CDS-

Z-3002-2024
Recall number
Z-3002-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

AM310B , Lot Number 20BBX607 ; AM310B , Lot Number 20FBO876 ; AM310B , Lot Number 20HBG464 ; AM310B , Lot Number 20HBT869 ; AM310B , Lot Number 20JBW307 ; AM310B , Lot Number 20XBG776 ; CDS780161K , Lot Number 19ABJ175 ; CDS780161K , Lot Number 19CBC247 ; CDS780161K , Lot Number 19DBJ688 ; CDS780161L , Lot Number 21FBM662 ; CDS780161L , Lot Number 21JBO079 ; CDS780161L , Lot Number 21KBU620 ; CDS780161L , Lot Number 22DBN197 ; CDS780161L , Lot Number 22EBE676 ; CDS780161L , Lot Number 22GBA238 ; CDS780161L , Lot Number 19FBZ495 ; CDS780161L , Lot Number 22HBH827 ; CDS780161L , Lot Number 22JBA466 ; CDS780161L , Lot Number 22JBR842 ; CDS780161L , Lot Number 19IBA021 ; CDS780161L , Lot Number 22LBG736 ; CDS780161L , Lot Number 23ABC482 ; CDS780161L , Lot Number 19KBD885 ; CDS780161L , Lot Number 23BBK773 ; CDS780161L , Lot Number 23DBH567 ; CDS780161L , Lot Number 20BBA048 ; CDS780161L , Lot Number 23EBW865 ; CDS780161L , Lot Number 23FBR465 ; CDS780161L , Lot Number 20CBF643 ; CDS780161L , Lot Number 23HBF094 ; CDS780161L , Lot Number 20DBQ527 ; CDS780161L , Lot Number 20EBT660 ; CDS780161L , Lot Number 23JBG854 ; CDS780161L , Lot Number 23KBG199 ; CDS780161L , Lot Number 20GBQ310 ; CDS780161L , Lot Number 20HBW040 ; CDS780161L , Lot Number 20KBQ319 ; CDS780161L , Lot Number 20LBP102 ; CDS780161L , Lot Number 20LBQ550 ; CDS780161L , Lot Number 21CBI795 ; CDS780161L , Lot Number 21DBA543 ; CDS780161L , Lot Number 21EBA173 ; CDS780170R , Lot Number 21HBH210 ; CDS780170R , Lot Number 19ABX183 ; CDS780170R , Lot Number 19CBG446 ; CDS780170R , Lot Number 19DBV563 ; CDS780170R , Lot Number 19GBW741 ; CDS780170R , Lot Number 19IBQ678 ; CDS780170R , Lot Number 20BBE129 ; CDS780170R , Lot Number 20HBH841 ; CDS780170R , Lot Number 20JBY348 ; CDS780170R , Lot Number 20KBE437 ; CDS780170R , Lot Number 21BBN563 ; CDS780170R , Lot Number 21EBO719 ; CDS780170S , Lot Number 21LBU027 ; CDS780170S , Lot Number 22ABC196 ; CDS780170S , Lot Number 22CBT534 ; CDS780170S , Lot Number 22DBB138 ; CDS780170S , Lot Number 22FBY456 ; CDS780170S , Lot Number 22LMJ227 ; CDS780170S , Lot Number 23AMB457 ; CDS780170S , Lot Number 23AMG031 ; CDS780170S , Lot Number 23BMG081 ; CDS840056N , Lot Number 19ABS578 ; CDS840056N , Lot Number 19CBF638 ; CDS840056N , Lot Number 19DBQ238 ; CDS840056N , Lot Number 19FBT067 ; CDS840056N , Lot Number 19JBJ675 ; CDS860039J , Lot Number 21GBL272 ; CDS860039J , Lot Number 20FBR859 ; CDS860039J , Lot Number 20HBH825 ; CDS860039J , Lot Number 20JBI204 ; CDS860039J , Lot Number 20KBJ538 ; CDS860039J , Lot Number 20LBV021 ; CDS860039J , Lot Number 21CBO329 ; CDS860039J , Lot Number 21EBA033 ; CDS860039J , Lot Number 21EBO476 ; CDS860047X , Lot Number 22KBF748 ; CDS860047X , Lot Number 23ABC310 ; CDS860047X , Lot Number 23BBN857 ; CDS860047X , Lot Number 23CBM719 ; CDS860047X , Lot Number 23CBR360 ; CDS860047X , Lot Number 23DBP426 ; CDS860047X , Lot Number 23EBK702 ; CDS860047X , Lot Number 23FBE714 ; CDS860047X , Lot Number 23GBU901 ; CDS860047X , Lot Number 23HBU599 ; CDS860047X , Lot Number 23IBO885 ; CDS920065R , Lot Number 22JLB054 ; CDS980089L , Lot Number 19BBE268 ; CDS980089L , Lot Number 19CBL613 ; CDS980089L , Lot Number 19FBL680 ; CDS980089L , Lot Number 19TBC919 ; CDS980089L , Lot Number 19JBK959 ; CDS980089M , Lot Number 21FBJ093 ; CDS980089M , Lot Number 21FBJ094 ; CDS980089M , Lot Number 21FBJ095 ; CDS980089M , Lot Number 21FBJ096 ; CDS980089M , Lot Number 21FBJ097 ; CDS980089M , Lot Number 21FBR314 ; CDS980089M , Lot Number 21HBG999 ; CDS980089M , Lot Number 21JBM584 ; CDS980089M , Lot Number 19KBH835 ; CDS980089M , Lot Number 20HBU008 ; CDS980089M , Lot Number 20LBI140 ; CDS980089M , Lot Number 21BBJ367 ; CDS980089N , Lot Number 22ABD323 ; CDS980089N , Lot Number 22ABD324 ; CDS980089N , Lot Number 22KBM192 ; CDS980089O , Lot Number 23CBW365 ; CDS980089O , Lot Number 23EBE453 ; CDS980089O , Lot Number 23GBB537 ; CDS980089O , Lot Number 23JBN802 ; CDS980089O , Lot Number 23LBJ396 ; CDS980201R , Lot Number 22CBB940 ; CDS980201R , Lot Number 22OBA201 ; CDS980203R , Lot Number 19ABW857 ; CDS980203R , Lot Number 19BBU024 ; CDS980203R , Lot Number 19DBY788 ; CDS980203R , Lot Number 19QBA275 ; CDS980203R , Lot Number 19SBB846 ; CDS980203R , Lot Number 19LBJ447 ; CDS980203R , Lot Number 20BBE176 ; CDS980203R , Lot Number 20DBT319 ; CDS980203R , Lot Number 20EBA269 ; CDS980203R , Lot Number 20HBI823 ; CDS980203R , Lot Number 20IBQ932 ; CDS980203R , Lot Number 20KBF449 ; CDS980203R , Lot Number 21ABI747 ; CDS980203S , Lot Number 21GBS679 ; CDS980203S , Lot Number 21IBV658 ; CDS980203S , Lot Number 21KBI373 ; CDS980203S , Lot Number 21KBK367 ; CDS980203S , Lot Number 21LBJ704 ; CDS980203S , Lot Number 22ABF195 ; CDS980203S , Lot Number 22FBG171 ; CDS980203S , Lot Number 22HBO399 ; CDS980203S , Lot Number 22HBS783 ; CDS980203S , Lot Number 22KBS200 ; CDS980203S , Lot Number 22LBH807 ; CDS980203S , Lot Number 22LBH959 ; CDS980203S , Lot Number 23ABR111 ; CDS980203S , Lot Number 23DBT154 ; CDS980203S , Lot Number 23HBT797 ; CDS980203S , Lot Number 23JBM122 ; CDS980203S , Lot Number 23LBC884 ; CDS980203S , Lot Number 21CBW683 ; CDS980374M , Lot Number 19DBV282 ; CDS980374M , Lot Number 19EBW414 ; CDS980374M , Lot Number 19GBF774 ; CDS980374M , Lot Number 19IBB514 ; CDS980374M , Lot Number 19LBE165 ; CDS980374M , Lot Number 20DBH025 ; CDS980374M , Lot Number 20FBJ581 ; CDS980374M , Lot Number 20IBD364 ; CDS980374M , Lot Number 20JBM273 ; CDS980374M , Lot Number 20KBL921 ; CDS980374M , Lot Number 21ABG498 ; CDS980374M , Lot Number 21CBF887 ; CDS980374O , Lot Number 21IBA010 ; CDS980374O , Lot Number 21IBT673 ; CDS980374O , Lot Number 22ABB423 ; CDS980374O , Lot Number 22OBM366 ; CDS980374O , Lot Number 22EBU213 ; CDS980374O , Lot Number 22GBE098 ; CDS980374O , Lot Number 22GBX430 ; CDS980374O , Lot Number 22JBN229 ; CDS980374O , Lot Number 22KBT771 ; CDS980374O , Lot Number 22LBM391 ; CDS980374O , Lot Number 23BBG819 ; CDS980374O , Lot Number 23CBT151 ; CDS980374P , Lot Number 23FBG020 ; CDS980374P , Lot Number 23FBV450 ; CDS980374P , Lot Number 23HBI049 ; CDS980374P , Lot Number 23IBQ190 ; CDS980374P , Lot Number 23KBB054 ; CDS980374P , Lot Number 23KBB055 ; CDS980374P , Lot Number 23KBB070 ; CDS980446T , Lot Number 21FBP535 ; CDS980446T , Lot Number 21FBT733 ; CDS980446T , Lot Number 21IBR112 ; CDS980446T , Lot Number 20GBJ881 ; CDS980446T , Lot Number 20GBW080 ; CDS980446T , Lot Number 20IBG082 ; CDS980446T , Lot Number 20LBS189 ; CDS980446T , Lot Number 21EBE589 ; CDS980579D , Lot Number 21FBN768 ; CDS980579D , Lot Number 21IBA072 ; CDS980579D , Lot Number 21JBC146 ; CDS980579D , Lot Number 22ABD373 ; CDS980579D , Lot Number 22BBU367 ; CDS980579D , Lot Number 19BBJ400 ; CDS980579D , Lot Number 22DBK641 ; CDS980579D , Lot Number 19DBE477 ; CDS980579D , Lot Number 19EBC589 ; CDS980579D , Lot Number 22FBN678 ; CDS980579D , Lot Number 19FBO184 ; CDS980579D , Lot Number 22HBF976 ; CDS980579D , Lot Number 22HBL188 ; CDS980579D , Lot Number 19HBY828 ; CDS980579D , Lot Number 19IBW711 ; CDS980579D , Lot Number 22LBE888 ; CDS980579D , Lot Number 23ABD648 ; CDS980579D , Lot Number 23ABP476 ; CDS980579D , Lot Number 19LBK646 ; CDS980579D , Lot Number 23DBD581 ; CDS980579D , Lot Number 23DBO915 ; CDS980579D , Lot Number 20BBA370 ; CDS980579D , Lot Number 23GBK604 ; CDS980579D , Lot Number 20DBB743 ; CDS980579D , Lot Number 23JBF547 ; CDS980579D , Lot Number 20FBR891 ; CDS980579D , Lot Number 20HBU165 ; CDS980579D , Lot Number 23LBM852 ; CDS980579D , Lot Number 24ABJ712 ; CDS980579D , Lot Number 20JBG228 ; CDS980579D , Lot Number 20LBG157 ; CDS980579D , Lot Number 21ABL742 ; CDS980579D , Lot Number 21EBI490 ; CDS980579D , Lot Number 21FBB075 ; CDS980809K , Lot Number 19BBK881 ; CDS980809K , Lot Number 19CBA199 ; CDS980809K , Lot Number 19CBV529 ; CDS980809K , Lot Number 19HBD987 ; CDS980809L , Lot Number 20CBP755 ; CDS980809L , Lot Number 20DBT299 ; CDS980809L , Lot Number 20EBF598 ; CDS980809L , Lot Number 20FBU281 ; CDS980809L , Lot Number 21CBQ757 ; CDS980809M , Lot Number 22CBK304 ; CDS980809M , Lot Number 22OBE744 ; CDS980809M , Lot Number 22EBG583 ; CDS980809M , Lot Number 22EBI113 ; CDS980809M , Lot Number 22JBP033 ; CDS980809M , Lot Number 23BBK767 ; CDS980809M , Lot Number 23DBI050 ; CDS980809M , Lot Number 23FBP394 ; CDS981185B , Lot Number 19CDB151 ; CDS981185B , Lot Number 19DDD096 ; CDS981185B , Lot Number 19FDA612 ; CDS981185B , Lot Number 19IDA540 ; CDS981185B , Lot Number 19LDB150 ; CDS981185B , Lot Number 20BDA647 ; CDS981185B , Lot Number 20DDB481 ; CDS981185B , Lot Number 20IDA733 ; CDS981185B , Lot Number 20LDA459 ; CDS981185B , Lot Number 21HDB855 ; CDS981185B , Lot Number 21IDA882 ; CDS981185B , Lot Number 21JDB377 ; CDS981185B , Lot Number 22CDC141 ; CDS981185B , Lot Number 22EDB625 ; CDS981185B , Lot Number 23ADB195 ; CDS981185B , Lot Number 23FDA168 ; CDS981185B , Lot Number 23GDA870 ; CDS981185B , Lot Number 23LDB380 ; CDS981185B , Lot Number 24BDB518 ; CDS981571P , Lot Number 20IBF435 ; CDS981571P , Lot Number 20JBD456 ; CDS981571P , Lot Number 20KBY135 ; CDS981571P , Lot Number 21ABG837 ; CDS981692J , Lot Number 21EME021 ; CDS981692J , Lot Number 21FMB792 ; CDS981692J , Lot Number 21FMD781 ; CDS981692J , Lot Number 21GMC528 ; CDS981692J , Lot Number 21HMF136 ; CDS981692J , Lot Number 21KMA503 ; CDS981692J , Lot Number 22AMA586 ; CDS981692J , Lot Number 22EMB645 ; CDS981692J , Lot Number 22GMB473 ; CDS981692J , Lot Number 22GMH942 ; CDS981692J , Lot Number 22IMD591 ; CDS981692J , Lot Number 22KMG745 ; CDS981692J , Lot Number 22LME628 ; CDS981692J , Lot Number 23CME129 ; CDS981692J , Lot Number 19CKB351 ; CDS981692J , Lot Number 19EKA839 ; CDS981692J , Lot Number 19IKA266 ; CDS981692J , Lot Number 19JKC199 ; CDS981692J , Lot Number 19LKB014 ; CDS981692J , Lot Number 20BKA891 ; CDS981692J , Lot Number 20GKB237 ; CDS981692J , Lot Number 20HKB816 ; CDS981692J , Lot Number 20KKA424 ; CDS981692J , Lot Number 20LKA784 ; CDS981985F , Lot Number 21FBL045 ; CDS981985F , Lot Number 21GBN303 ; CDS981985F , Lot Number 22EBF907 ; CDS981985F , Lot Number 22GBG130 ; CDS981985F , Lot Number 22GBV850 ; CDS981985F , Lot Number 19GBX996 ; CDS981985F , Lot Number 22IBS673 ; 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CDS983088J, Lot Number 22DBO479; CDS983088J, Lot Number 23ABM168; CDS983088J, Lot Number 22LBB288; CDS983088J, Lot Number 22JBW377; CDS983088J, Lot Number 22IBR946; CDS983088J, Lot Number 22HBM640; CDS983088J, Lot Number 22HBN931; CDS983088J, Lot Number 22HBM642; CDS983088J, Lot Number 22DBO479; CDS983126B , Lot Number 19ABN016 ; CDS983126B , Lot Number 19CBK514 ; CDS983126B , Lot Number 19FBF166 ; CDS983126B , Lot Number 19SBG848 ; CDS983126C , Lot Number 19KBC140 ; CDS983126C , Lot Number 20ABV536 ; CDS983126C , Lot Number 20HBH783 ; CDS983126C , Lot Number 20IBI376 ; CDS983126C , Lot Number 20JBT062 ; CDS983126C , Lot Number 20LBI163 ; CDS983126C , Lot Number 21ABV524 ; CDS983139A , Lot Number 19ABM547 ; CDS983139A , Lot Number 19CBF260 ; CDS983139A , Lot Number 19CBK755 ; CDS983139A , Lot Number 19DBF987 ; CDS983139A , Lot Number 19FBJ779 ; CDS983139A , Lot Number 19FBZ756 ; CDS983139A , Lot Number 19GBX147 ; CDS983139A , Lot Number 19IBO536 ; CDS983139A , Lot Number 19JBI350 ; CDS983139A , Lot Number 19VBF786 ; CDS983139B , Lot Number 21FBJ082 ; CDS983139B , Lot Number 21GBE864 ; CDS983139B , Lot Number 21HBC597 ; CDS983139B , Lot Number 21LBM269 ; CDS983139B , Lot Number 22ABL217 ; CDS983139B , Lot Number 22BBJ850 ; CDS983139B , Lot Number 22BBV592 ; CDS983139B , Lot Number 20CBN616 ; CDS983139B , Lot Number 20DBM218 ; CDS983139B , Lot Number 20FBD832 ; CDS983139B , Lot Number 20HBV523 ; CDS983139B , Lot Number 20IBS611 ; CDS983139B , Lot Number 20LBW853 ; CDS983139B , Lot Number 20XBH113 ; CDS983142C , Lot Number 21FBN817 ; CDS983142C , Lot Number 22ABT796 ; CDS983142C , Lot Number 22ABT797 ; CDS983142C , Lot Number 22BBA393 ; CDS983142C , Lot Number 22IBB522 ; CDS983142C , Lot Number 20DBH141 ; CDS983142C , Lot Number 20EBJ961 ; CDS983142C , Lot Number 20IBL516 ; CDS983178D , Lot Number 21GBN275 ; CDS983178D , Lot Number 21IBT664 ; CDS983178D , Lot Number 21JBO038 ; CDS983178D , Lot Number 21LBG253 ; CDS983178D , Lot Number 22BBA124 ; CDS983178D , Lot Number 19ABF948 ; CDS983178D , Lot Number 19BBD305 ; CDS983178D , Lot Number 22CBL563 ; CDS983178D , Lot Number 19CBW884 ; CDS983178D , Lot Number 22EBC371 ; CDS983178D , Lot Number 22EBD213 ; CDS983178D , Lot Number 19EBZ746 ; CDS983178D , Lot Number 19GBB101 ; CDS983178D , Lot Number 19IBC345 ; CDS983178D , Lot Number 19IBC633 ; CDS983178D , Lot Number 19JBL299 ; CDS983178D , Lot Number 19KBZ024 ; CDS983178D , Lot Number 20ABH048 ; CDS983178D , Lot Number 20BBQ317 ; CDS983178D , Lot Number 20CBP836 ; CDS983178D , Lot Number 20EBG186 ; CDS983178D , Lot Number 20GBD065 ; CDS983178D , Lot Number 20IBN724 ; CDS983178D , Lot Number 20JBX943 ; CDS983178D , Lot Number 21ABO804 ; CDS983178D , Lot Number 21ABP999 ; CDS983178D , Lot Number 21DBC491 ; CDS983178D , Lot Number 21FBC638 ; CDS983178D , Lot Number 21FBC639 ; CDS983178F , Lot Number 22GBB109 ; CDS983178F , Lot Number 22IBC429 ; CDS983178F , Lot Number 22JBC334 ; CDS983178G , Lot Number 22KBO917 ; CDS983178I , Lot Number 23ABD213 ; CDS983178I , Lot Number 23ABT114 ; CDS983178I , Lot Number 23BBU908 ; CDS983178I , Lot Number 23CBG894 ; CDS983178I , Lot Number 23DBE126 ; CDS983178I , Lot Number 23GBI251 ; CDS983178I , Lot Number 23GBI927 ; CDS983178I , Lot Number 23HBO013 ; CDS983178I , Lot Number 23JBQ340 ; CDS983178I , Lot Number 23KBF403 ; CDS983178I , Lot Number 23LBI653 ; CDS983178I , Lot Number 24BBC965 ; CDS983181F , Lot Number 22FBX036 ; CDS983181F , Lot Number 22IBJ058 ; CDS983181F , Lot Number 22IBQ523 ; CDS983181F , Lot Number 22LBT176 ; CDS983181F , Lot Number 23ABT115 ; CDS983181F , Lot Number 23BBJ894 ; CDS983181F , Lot Number 23EBJ325 ; CDS983181F , Lot Number 23FBH145 ; CDS983181F , Lot Number 23GBO776 ; CDS983181F , Lot Number 23GBP590 ; CDS983181F , Lot Number 23IBC608 ; CDS983181F , Lot Number 23KBE427 ; CDS983181F , Lot Number 23KBF412 ; CDS983184I , Lot Number 22GBV926 ; CDS983184I , Lot Number 22IBJ687 ; CDS983184I , Lot Number 22IBO795 ; CDS983184I , Lot Number 22LBB795 ; CDS983184I , Lot Number 22LBP673 ; CDS983184I , Lot Number 23BBH106 ; CDS983184I , Lot Number 23BBU916 ; CDS983184I , Lot Number 23CBT619 ; CDS983184I , Lot Number 23EBE530 ; CDS983184I , Lot Number 23FBJ754 ; CDS983184I , Lot Number 23HBP974 ; CDS983184I , Lot Number 23HBY087 ; CDS983184I , Lot Number 23JBF563 ; CDS983184I , Lot Number 23KBI669 ; CDS983184I , Lot Number 23KBM394 ; CDS983184I , Lot Number 23LBD939 ; CDS983184I , Lot Number 24ABI467 ; CDS983209I , Lot Number 21GBG958 ; CDS983209I , Lot Number 21IBV512 ; CDS983209I , Lot Number 21KBW919 ; CDS983209I , Lot Number 22ABX999 ; CDS983209I , Lot Number 22BBA120 ; CDS983209I , Lot Number 22CBD916 ; CDS983209I , Lot Number 22EBB414 ; CDS983209I , Lot Number 22EBD173 ; CDS983209I , Lot Number 22FBN422 ; CDS983209I , Lot Number 19FBM137 ; CDS983209I , Lot Number 19SBE417 ; CDS983209I , Lot Number 19HBM775 ; CDS983209I , Lot Number 19JBS127 ; CDS983209I , Lot Number 19KBZ007 ; CDS983209I , Lot Number 19LBW572 ; CDS983209I , Lot Number 20BBN555 ; CDS983209I , Lot Number 20CBX026 ; CDS983209I , Lot Number 20DBG926 ; CDS983209I , Lot Number 20DBN227 ; CDS983209I , Lot Number 20EBT051 ; CDS983209I , Lot Number 21DBH496 ; CDS983209I , Lot Number 21EBQ888 ; CDS983209J , Lot Number 22JBC280 ; CDS983209J , Lot Number 23ABO115 ; CDS983209K , Lot Number 23CBV670 ;

Distribution pattern

Worldwide distribution.

device · product 23 of 81

Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288

Z-3003-2024
Recall number
Z-3003-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ17400B, Lot Number 23ABV075; DYNJ17400B, Lot Number 23ABV141; DYNJ17400B, Lot Number 22KBA557; DYNJ17400B, Lot Number 22GBJ307; DYNJ17400B, Lot Number 22DBU457; DYNJ32049A , Lot Number 19AKB211 ; DYNJ32049A , Lot Number 19CKA247 ; DYNJ44987G , Lot Number 21FBJ607 ; DYNJ44987G , Lot Number 21IBE237 ; DYNJ44987G , Lot Number 21KBA883 ; DYNJ44987G , Lot Number 21LBO984 ; DYNJ44987G , Lot Number 22CBN087 ; DYNJ44987G , Lot Number 20BBQ959 ; DYNJ44987G , Lot Number 20FBI170 ; DYNJ44987G , Lot Number 20JBL731 ; DYNJ44987G , Lot Number 21ABF141 ; DYNJ44987G , Lot Number 21CBF976 ; DYNJ44987G , Lot Number 21DBW445 ; DYNJ66288, Lot Number 20DBE878

Distribution pattern

Worldwide distribution.

device · product 24 of 81

Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A; 6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A; 7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH; 8) PACK,BREAST BIOPSY, Pack Number DYNDL1498; 9) BONE MARROW PACK, Pack Number DYNJ0628436I ; 10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K; 11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH; 12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ; 13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH; 14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ; 15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ; 16) BIOPSY TRAY , Pack Number DYNJ31585C ; 17) BONE MARROW KIT PK, Pack Number DYNJ37526; 18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ; 19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ; 20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ; 21) BIOPSY TRAY , Pack Number DYNJ49368; 22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ; 23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550; 24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ; 25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D; 26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B; 27) PACK,FETOSCOPY, Pack Number DYNJ906905B; 28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035; 29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ; 30) BIOPSY TRAY , Pack Number SPEC0150 ; 31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B; 32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279

Z-3004-2024
Recall number
Z-3004-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS840215O , Lot Number 21HBJ135 ; CDS840215O , Lot Number 21JBS174 ; CDS840215O , Lot Number 22ABB090 ; CDS840215O , Lot Number 22ABS124 ; CDS840215O , Lot Number 22EBA066 ; CDS840215O , Lot Number 22GBQ007 ; CDS840215O , Lot Number 22GBQ009 ; CDS840215O , Lot Number 22HBU942 ; CDS840215O , Lot Number 23ABD369 ; CDS840215O , Lot Number 23CBO683 ; CDS840215O , Lot Number 23FBT988 ; CDS840215O , Lot Number 23GBI919 ; CDS840215O , Lot Number 23JBK910 ; CDS840215O , Lot Number 24ABE598 ; CDS840215O , Lot Number 20LBA006 ; CDS840215O , Lot Number 21ABQ774 ; CDS840215O , Lot Number 21ABR763 ; CDS840215O , Lot Number 21ABT392 ; CDS840215O , Lot Number 21CBM879 ; CDS840215O , Lot Number 21CBY329 ; CDS840215O , Lot Number 21DBP547 ; CDS981237F , Lot Number 19BBH974 ; CDS981237F , Lot Number 19DBZ760 ; CDS981237F , Lot Number 19GBG896 ; CDS981237F , Lot Number 19GBR697 ; CDS981237F , Lot Number 19IBK312 ; CDS981237F , Lot Number 19JBS472 ; CDS981237F , Lot Number 19VBE313 ; CDS981237F , Lot Number 19LBQ636 ; CDS981237F , Lot Number 20BBS514 ; DYNDA1217A , Lot Number 21JBQ356 ; DYNDC2239, Lot Number 21JBL152 ; DYNDH1187A, Lot Number 22HMH338; DYNDH1187A, Lot Number 22FMA363; DYNDH1187A, Lot Number 22EBC538; DYNDH1187A, Lot Number 22OBA249; DYNDH1187A, Lot Number 22BBZ459; DYNDH1187A, Lot Number 22HMH338; DYNDH1187A, Lot Number 22FMA363; DYNDH1187A, Lot Number 22EBC538; DYNDH1187A, Lot Number 22OBA249; DYNDH1187A, Lot Number 22BBZ459; DYNDH1286A, Lot Number 23FMA562; DYNDH1286A, Lot Number 23DME451; DYNDH1286A, Lot Number 23AMH934; DYNDH1286A , Lot Number 23JMC410 ; DYNDH1286AH, Lot Number 23FMA562; DYNDH1286AH, Lot Number 23DME451; DYNDH1286AH, Lot Number 23AMH934; DYNDH1286AH, Lot Number 23JMC410 ; DYNDL1498, Lot Number 21JBM328 ; DYNJ0628436I , Lot Number 20CDA324 ; DYNJ0628436I , Lot Number 20DDB806 ; DYNJ0628436I , Lot Number 20FDA658 ; DYNJ0628436I , Lot Number 20IDB329 ; DYNJ0628436I , Lot Number 20LDC229 ; DYNJ0628436I , Lot Number 21ADA277 ; DYNJ0628436I , Lot Number 21DDB241 ; DYNJ0628436I , Lot Number 21IDA223 ; DYNJ0628436I , Lot Number 21IDB517 ; DYNJ0628436I , Lot Number 21JDA063 ; DYNJ0628436I , Lot Number 21JDA834 ; DYNJ0628436I , Lot Number 21JDB718 ; DYNJ0660035K, Lot Number 24ALA341; DYNJ0660035K, Lot Number 23GLA731; DYNJ0660035K, Lot Number 23DLA072; DYNJ0660035KH, Lot Number 24ALA341; DYNJ0660035KH, Lot Number 23GLA731; DYNJ0660035KH, Lot Number 23DLA072; DYNJ0706869I , Lot Number 20JMC336 ; DYNJ0706869I , Lot Number 20LMD691 ; DYNJ0706869I , Lot Number 21DME377 ; DYNJ0706869I , Lot Number 21FMD242 ; DYNJ0706869I , Lot Number 21LMC086 ; DYNJ0706869I , Lot Number 22AMC817 ; DYNJ0706869I , Lot Number 22DME371 ; DYNJ0706869I , Lot Number 22EMD666 ; DYNJ0706869I , Lot Number 22FMA242 ; DYNJ0706869I , Lot Number 22GMD755 ; DYNJ0706869I , Lot Number 22IMB513 ; DYNJ0706869I , Lot Number 22IMB656 ; DYNJ0706869I , Lot Number 22LMA106 ; DYNJ0706869I , Lot Number 23BMG720 ; DYNJ0706869I , Lot Number 23DMB102 ; DYNJ0706869I , Lot Number 23EMI240 ; DYNJ0706869I , Lot Number 23FMH902 ; DYNJ0706869I , Lot Number 23HMC291 ; DYNJ0706869I , Lot Number 23IMG874 ; DYNJ0706869I , Lot Number 23JMG263 ; DYNJ0706869I , Lot Number 23KMI951 ; DYNJ0706869I , Lot Number 19AKC096 ; DYNJ0706869I , Lot Number 19BKC989 ; DYNJ0706869I , Lot Number 19DKA116 ; DYNJ0706869I , Lot Number 19EKA641 ; DYNJ0706869I , Lot Number 19FKB385 ; DYNJ0706869I , Lot Number 19HKA718 ; DYNJ0706869I , Lot Number 19IKA169 ; DYNJ0706869I , Lot Number 19KKC060 ; DYNJ0706869I , Lot Number 20BKB668 ; DYNJ0706869I , Lot Number 20EKA822 ; DYNJ0706869I , Lot Number 20HKA809 ; DYNJ0706869IH, Lot Number 21DME377 ; DYNJ0706869IH, Lot Number 21FMD242 ; DYNJ0706869IH, Lot Number 19AKC096 ; DYNJ0706869IH, Lot Number 19BKC989 ; DYNJ0706869IH, Lot Number 21LMC086 ; DYNJ0706869IH, Lot Number 19DKA116 ; DYNJ0706869IH, Lot Number 19EKA641 ; DYNJ0706869IH, Lot Number 19FKB385 ; DYNJ0706869IH, Lot Number 22AMC817 ; DYNJ0706869IH, Lot Number 19HKA718 ; DYNJ0706869IH, Lot Number 19IKA169 ; DYNJ0706869IH, Lot Number 19KKC060 ; DYNJ0706869IH, Lot Number 22DME371 ; DYNJ0706869IH, Lot Number 22EMD666 ; DYNJ0706869IH, Lot Number 22FMA242 ; DYNJ0706869IH, Lot Number 22GMD755 ; DYNJ0706869IH, Lot Number 22IMB513 ; DYNJ0706869IH, Lot Number 22IMB656 ; DYNJ0706869IH, Lot Number 22LMA106 ; DYNJ0706869IH, Lot Number 23BMG720 ; DYNJ0706869IH, Lot Number 23DMB102 ; DYNJ0706869IH, Lot Number 23EMI240 ; DYNJ0706869IH, Lot Number 23FMH902 ; DYNJ0706869IH, Lot Number 23HMC291 ; DYNJ0706869IH, Lot Number 23IMG874 ; DYNJ0706869IH, Lot Number 23JMG263 ; DYNJ0706869IH, Lot Number 23KMI951 ; DYNJ20953F , Lot Number 21ELA134 ; DYNJ20953F , Lot Number 21GLA448 ; DYNJ20953F , Lot Number 21HLA653 ; DYNJ20953F , Lot Number 21JLA115 ; DYNJ20953F , Lot Number 21LLA043 ; DYNJ20953F , Lot Number 22ALA485 ; DYNJ20953F , Lot Number 22CLA673 ; DYNJ20953F , Lot Number 22DLA696 ; DYNJ20953F , Lot Number 19AKC194 ; DYNJ20953F , Lot Number 19CKB503 ; DYNJ20953F , Lot Number 19EKB212 ; DYNJ20953F , Lot Number 19FKC476 ; DYNJ20953F , Lot Number 19HKA346 ; DYNJ20953F , Lot Number 19IKB981 ; DYNJ20953F , Lot Number 19JKA937 ; DYNJ20953F , Lot Number 19KKB073 ; DYNJ20953F , Lot Number 20AKB265 ; DYNJ20953F , Lot Number 20DKA525 ; DYNJ20953F , Lot Number 20EKA867 ; DYNJ20953F , Lot Number 20FKB636 ; DYNJ20953F , Lot Number 20HKB650 ; DYNJ20953F , Lot Number 20JKB301 ; DYNJ20953F , Lot Number 20KKA781 ; DYNJ20953F , Lot Number 21AKA562 ; DYNJ20953F , Lot Number 21DKA141 ; DYNJ28856D , Lot Number 19ALA181 ; DYNJ28856D , Lot Number 19CLA313 ; DYNJ28856D , Lot Number 19DLA642 ; DYNJ28856D , Lot Number 19JLA386 ; DYNJ28856D , Lot Number 19LLA006 ; DYNJ28856D , Lot Number 20ALA170 ; DYNJ28856D , Lot Number 20CLA553 ; DYNJ28856D , Lot Number 20DLA268 ; DYNJ28856D , Lot Number 21ALA407 ; DYNJ28856D , Lot Number 21BLA034 ; DYNJ28856D , Lot Number 21CLA419 ; DYNJ31585C , Lot Number 21ELA814 ; DYNJ31585C , Lot Number 21JLA477 ; DYNJ31585C , Lot Number 22BLA693 ; DYNJ31585C , Lot Number 22ILA016 ; DYNJ31585C , Lot Number 22KLA729 ; DYNJ31585C , Lot Number 24ALA690 ; DYNJ31585C , Lot Number 19CKD774 ; DYNJ31585C , Lot Number 19HKC979 ; DYNJ31585C , Lot Number 20BKB640 ; DYNJ31585C , Lot Number 20KKA827 ; DYNJ37526, Lot Number 19CDA532 ; DYNJ37526, Lot Number 19FDC312 ; DYNJ37526, Lot Number 20DDA550 ; DYNJ37526, Lot Number 21BDA027 ; DYNJ37526, Lot Number 22BDB609 ; DYNJ37526, Lot Number 22BDC211 ; DYNJ37526, Lot Number 24BDB879 ; DYNJ38414B , Lot Number 21DLA560 ; DYNJ38414B , Lot Number 21ELA636 ; DYNJ38414B , Lot Number 21GLA068 ; DYNJ38414B , Lot Number 21HLA711 ; DYNJ38414B , Lot Number 21JLA068 ; DYNJ38414B , Lot Number 21LLA898 ; DYNJ38414B , Lot Number 22CLA518 ; DYNJ38414B , Lot Number 22ELA196 ; DYNJ38414B , Lot Number 22FLA933 ; DYNJ38414B , Lot Number 22GLA926 ; DYNJ38414B , Lot Number 22HLB262 ; DYNJ38414B , Lot Number 22JLA623 ; DYNJ38414B , Lot Number 23ALA320 ; DYNJ38414B , Lot Number 23DLA256 ; DYNJ38414B , Lot Number 23DLB088 ; DYNJ38414B , Lot Number 23ELA575 ; DYNJ38414B , Lot Number 23FLB074 ; DYNJ38414B , Lot Number 23HLA831 ; DYNJ38414B , Lot Number 23JLA563 ; DYNJ38414B , Lot Number 23KLA596 ; DYNJ38414B , Lot Number 24ALA832 ; DYNJ38414B , Lot Number 19AKC074 ; DYNJ38414B , Lot Number 19CKC932 ; DYNJ38414B , Lot Number 19EKB260 ; DYNJ38414B , Lot Number 19EKD084 ; DYNJ38414B , Lot Number 19GKA529 ; DYNJ38414B , Lot Number 19GKC252 ; DYNJ38414B , Lot Number 19HKC005 ; DYNJ38414B , Lot Number 19JKA355 ; DYNJ38414B , Lot Number 19LKB738 ; DYNJ38414B , Lot Number 20AKB834 ; DYNJ38414B , Lot Number 20BKB556 ; DYNJ38414B , Lot Number 20FKA065 ; DYNJ38414B , Lot Number 20FKB988 ; DYNJ38414B , Lot Number 20JKB019 ; DYNJ38414B , Lot Number 20KKA574 ; DYNJ38414B , Lot Number 21AKA080 ; DYNJ42702D , Lot Number 19ADA279 ; DYNJ42702D , Lot Number 19BDA365 ; DYNJ42702D , Lot Number 19BDD481 ; DYNJ42702D , Lot Number 19EDC319 ; DYNJ42702D , Lot Number 19FDB945 ; DYNJ42702D , Lot Number 19IDA212 ; DYNJ42702D , Lot Number 19JDA646 ; DYNJ42702D , Lot Number 19JDC432 ; DYNJ42702D , Lot Number 20BDA399 ; DYNJ42702D , Lot Number 20DDA234 ; DYNJ42702D , Lot Number 20DDA364 ; DYNJ42702D , Lot Number 20DDB590 ; DYNJ42702D , Lot Number 20IDC706 ; DYNJ42702D , Lot Number 20LDB764 ; DYNJ42702D , Lot Number 21ADA332 ; DYNJ42702D , Lot Number 21BDB947 ; DYNJ42702D , Lot Number 21EDB182 ; DYNJ42702D , Lot Number 21HDB001 ; DYNJ42702D , Lot Number 21IDA042 ; DYNJ42702D , Lot Number 22BDB745 ; DYNJ42702D , Lot Number 22CDC225 ; DYNJ42702D , Lot Number 22FDB912 ; DYNJ42702D , Lot Number 22KDB221 ; DYNJ42702D , Lot Number 23BDB853 ; DYNJ42702D , Lot Number 23DDA540 ; DYNJ42702D , Lot Number 23FDA089 ; DYNJ42702D , Lot Number 23GDA365 ; DYNJ42702D , Lot Number 23JDC551 ; DYNJ42702D , Lot Number 23LDC015 ; DYNJ42702D , Lot Number 24BDB395 ; DYNJ43493A , Lot Number 19ABM222 ; DYNJ49368, Lot Number 21GBU401 ; DYNJ49368, Lot Number 21IBJ806 ; DYNJ49368, Lot Number 21KBM934 ; DYNJ49368, Lot Number 21LBW773 ; DYNJ49368, Lot Number 22CBV642 ; DYNJ49368, Lot Number 19CBA603 ; DYNJ49368, Lot Number 22DBP231 ; DYNJ49368, Lot Number 19PBC340 ; DYNJ49368, Lot Number 22FBD715 ; DYNJ49368, Lot Number 19FBH514 ; DYNJ49368, Lot Number 22GBV458 ; DYNJ49368, Lot Number 19GBN956 ; DYNJ49368, Lot Number 22JBQ138 ; DYNJ49368, Lot Number 22KBJ578 ; DYNJ49368, Lot Number 22LBQ363 ; DYNJ49368, Lot Number 19VBE690 ; DYNJ49368, Lot Number 23ABP599 ; DYNJ49368, Lot Number 23CBD529 ; DYNJ49368, Lot Number 23CBR420 ; DYNJ49368, Lot Number 23DBM035 ; DYNJ49368, Lot Number 23EBL513 ; DYNJ49368, Lot Number 20CBH411 ; DYNJ49368, Lot Number 23GBH227 ; DYNJ49368, Lot Number 20DBJ728 ; DYNJ49368, Lot Number 23IBC420 ; DYNJ49368, Lot Number 20FBU558 ; DYNJ49368, Lot Number 23JBX049 ; DYNJ49368, Lot Number 20LBL396 ; DYNJ49368, Lot Number 21ABD738 ; DYNJ49368, Lot Number 21CBS175 ; DYNJ49368, Lot Number 21EBL511 ; DYNJ50740A , Lot Number 22ABE281 ; DYNJ50740A , Lot Number 22DBS385 ; DYNJ50740A , Lot Number 19EBL176 ; DYNJ50740A , Lot Number 22FBO930 ; DYNJ50740A , Lot Number 22GBT984 ; DYNJ50740A , Lot Number 19KBY078 ; DYNJ50740A , Lot Number 19LBI960 ; DYNJ50740A , Lot Number 20WBC156 ; DYNJ66550, Lot Number 20FLA484 ; DYNJ66550, Lot Number 20GLA274 ; DYNJ66550, Lot Number 20GLA442 ; DYNJ66550, Lot Number 20ILA192 ; DYNJ66550A , Lot Number 20JLA316 ; DYNJ66550A , Lot Number 20KLA061 ; DYNJ66550A , Lot Number 20KLA251 ; DYNJ66550A , Lot Number 21BLA448 ; DYNJ66550A , Lot Number 21HLA027 ; DYNJ66550A , Lot Number 21ILA340 ; DYNJ66550A , Lot Number 21KLB095 ; DYNJ66550A , Lot Number 22BLB208 ; DYNJ66550A , Lot Number 22CLB050 ; DYNJ66550A , Lot Number 22DLA315 ; DYNJ903942D, Lot Number 21GBO392 ; DYNJ903942D, Lot Number 21JBM620 ; DYNJ903942D, Lot Number 21KBS603 ; DYNJ903942D, Lot Number 21KBS604 ; DYNJ903942D, Lot Number 22ABD050 ; DYNJ903942D, Lot Number 22MBA673 ; DYNJ903942D, Lot Number 22BBS845 ; DYNJ903942D, Lot Number 22DBG084 ; DYNJ903942D, Lot Number 22FBM577 ; DYNJ903942D, Lot Number 22FBM578 ; DYNJ903942D, Lot Number 22FBM589 ; DYNJ903942D, Lot Number 22IBG104 ; DYNJ903942D, Lot Number 22JBP648 ; DYNJ903942D, Lot Number 22JBP649 ; DYNJ903942D, Lot Number 22KBN933 ; DYNJ903942D, Lot Number 23ABE488 ; DYNJ903942D, Lot Number 23ABO256 ; DYNJ903942D, Lot Number 23ABP894 ; DYNJ903942D, Lot Number 23ABS767 ; DYNJ903942D, Lot Number 23CBI126 ; DYNJ903942D, Lot Number 23CBQ109 ; DYNJ903942D, Lot Number 23DBM169 ; DYNJ903942D, Lot Number 23DBR799 ; DYNJ903942D, Lot Number 23EBV305 ; DYNJ903942D, Lot Number 23EBX153 ; DYNJ903942D, Lot Number 23FBE572 ; DYNJ903942D, Lot Number 23GBQ051 ; DYNJ903942D, Lot Number 23HBY686 ; DYNJ903942D, Lot Number 23JBD675 ; DYNJ903942D, Lot Number 23KBM793 ; DYNJ903942D, Lot Number 23LBP048 ; DYNJ903942D, Lot Number 23LBP853 ; DYNJ903942D, Lot Number 24ABE247 ; DYNJ903942D, Lot Number 24ABH578 ; DYNJ903942D, Lot Number 19GKC678 ; DYNJ903942D, Lot Number 19IKB896 ; DYNJ903942D, Lot Number 19JKB279 ; DYNJ903942D, Lot Number 19LKA016 ; DYNJ903942D, Lot Number 20AKA689 ; DYNJ903942D, Lot Number 20BKB196 ; DYNJ903942D, Lot Number 20CKA097 ; DYNJ903942D, Lot Number 20CKA804 ; DYNJ903942D, Lot Number 20EKB749 ; DYNJ903942D, Lot Number 20GKA184 ; DYNJ903942D, Lot Number 20GKB636 ; DYNJ903942D, Lot Number 21AKA242 ; DYNJ903942D, Lot Number 21BKA494 ; DYNJ903942D, Lot Number 21CKA499 ; DYNJ903942D, Lot Number 21CKB142 ; DYNJ903942D, Lot Number 21DKA509 ; DYNJ903942D, Lot Number 21EKA062 ; DYNJ904158B, Lot Number 19ABN292 ; DYNJ904158B, Lot Number 19BBO282 ; DYNJ904158B, Lot Number 19CBI653 ; DYNJ906905B, Lot Number 22HMF046 ; DYNJ906905B, Lot Number 22JMG038 ; DYNJS3035, Lot Number 21GBL947 ; DYNJS3035, Lot Number 21JBL374 ; DYNJS3035, Lot Number 21KBF313 ; DYNJS3035, Lot Number 21KBP406 ; DYNJS3035, Lot Number 21KBW671 ; DYNJS3035, Lot Number 21LBK410 ; DYNJS3035, Lot Number 19ABP640 ; DYNJS3035, Lot Number 22CBV726 ; DYNJS3035, Lot Number 19CBT667 ; DYNJS3035, Lot Number 22DBJ128 ; DYNJS3035, Lot Number 22FBU254 ; DYNJS3035, Lot Number 19EBZ680 ; DYNJS3035, Lot Number 19FBH129 ; DYNJS3035, Lot Number 22HBM446 ; DYNJS3035, Lot Number 22IBB171 ; DYNJS3035, Lot Number 22IBK248 ; DYNJS3035, Lot Number 19HBN094 ; DYNJS3035, Lot Number 19IBS848 ; DYNJS3035, Lot Number 22KBN711 ; DYNJS3035, Lot Number 22KBQ879 ; DYNJS3035, Lot Number 19VBF591 ; DYNJS3035, Lot Number 19LBX193 ; DYNJS3035, Lot Number 20BBD198 ; DYNJS3035, Lot Number 20BBJ243 ; DYNJS3035, Lot Number 20BBR079 ; DYNJS3035, Lot Number 23GBC631 ; DYNJS3035, Lot Number 23GBU967 ; DYNJS3035, Lot Number 23HBW879 ; DYNJS3035, Lot Number 20HBM215 ; DYNJS3035, Lot Number 20IBL253 ; DYNJS3035, Lot Number 20IBM444 ; DYNJS3035, Lot Number 20LBE454 ; DYNJS3035, Lot Number 21ABW073 ; DYNJS3035, Lot Number 21DBG410 ; DYNJS3035, Lot Number 21DBT234 ; DYNJS3035, Lot Number 21FBE207 ; DYNJT1911D , Lot Number 21GBM854 ; DYNJT1911D , Lot Number 21HBL482 ; DYNJT1911D , Lot Number 21JBV094 ; DYNJT1911D , Lot Number 21LBD977 ; DYNJT1911D , Lot Number 19ABM480 ; DYNJT1911D , Lot Number 22CBP276 ; DYNJT1911D , Lot Number 19CBT157 ; DYNJT1911D , Lot Number 22DBQ570 ; DYNJT1911D , Lot Number 22FBP864 ; DYNJT1911D , Lot Number 19FBH479 ; DYNJT1911D , Lot Number 22HBV267 ; DYNJT1911D , Lot Number 22JBG862 ; DYNJT1911D , Lot Number 19TBA995 ; DYNJT1911D , Lot Number 22LBD905 ; DYNJT1911D , Lot Number 19KBI818 ; DYNJT1911D , Lot Number 20BBX648 ; DYNJT1911D , Lot Number 20DBF498 ; DYNJT1911D , Lot Number 20EBJ723 ; DYNJT1911D , Lot Number 20GBC611 ; DYNJT1911D , Lot Number 20HBO933 ; DYNJT1911D , Lot Number 20KBV620 ; DYNJT1911D , Lot Number 20LBX239 ; DYNJT1911D , Lot Number 21BBO242 ; DYNJT1911D , Lot Number 21DBP011 ; SPEC0150 , Lot Number 21JBS825 ; SPEC0196B, Lot Number 21HBP822 ; SPEC0196B, Lot Number 21HBP823 ; SPEC0196B, Lot Number 21LBS523 ; SPEC0196B, Lot Number 22BBG423 ; SPEC0196B, Lot Number 19ABY909 ; SPEC0196B, Lot Number 22DBD292 ; SPEC0196B, Lot Number 22FBC357 ; SPEC0196B, Lot Number 22IBC784 ; SPEC0196B, Lot Number 22IBQ364 ; SPEC0196B, Lot Number 22JBR506 ; SPEC0196B, Lot Number 23ABA700 ; SPEC0196B, Lot Number 23BBD104 ; SPEC0196B, Lot Number 23EBI451 ; SPEC0196B, Lot Number 23EBX572 ; SPEC0196B, Lot Number 23FBB555 ; SPEC0196B, Lot Number 20CBB650 ; SPEC0196B, Lot Number 23GBJ028 ; SPEC0196B, Lot Number 20CBY142 ; SPEC0196B, Lot Number 23HBM323 ; SPEC0196B, Lot Number 20GBH090 ; SPEC0196B, Lot Number 20KBT647 ; SPEC0196B, Lot Number 20KBT648 ; SPEC0196B, Lot Number 21ABX189 ; SPEC0196B, Lot Number 21CBN263 ; SPEC0196B, Lot Number 21CBN441 ; SPEC0279 , Lot Number 23LBF037

Distribution pattern

Worldwide distribution.

device · product 25 of 81

Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ66109A ; 6) PERINEAL PACK , Pack Number DYNJ69895; 7) LIVER 2018, Pack Number DYNJ905655A; 8) UROLOGY PACK, Pack Number DYNJT2255M

Z-3005-2024
Recall number
Z-3005-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS983922F , Lot Number 19BDC122 ; CDS983922F , Lot Number 19CDC327 ; CDS983922F , Lot Number 19EDB619 ; CDS983922F , Lot Number 19HDB982 ; CDS983922F , Lot Number 19JDA589 ; CDS983922F , Lot Number 19JDC196 ; CDS983922F , Lot Number 20DDB450 ; CDS983922F , Lot Number 20FDB626 ; CDS983922F , Lot Number 20GDA441 ; CDS983922F , Lot Number 20HDA774 ; CDS983922F , Lot Number 20IDA727 ; CDS983922F , Lot Number 20JDC665 ; CDS983922F , Lot Number 21DDB315 ; DYNJ27442U , Lot Number 21HBM391 ; DYNJ27442U , Lot Number 21KBS771 ; DYNJ27442U , Lot Number 21LBY698 ; DYNJ39700B , Lot Number 20CBK667 ; DYNJ39700B , Lot Number 20DBC549 ; DYNJ39700B , Lot Number 20IMA568 ; DYNJ39700B , Lot Number 20KMA519 ; DYNJ39700B , Lot Number 20LME505 ; DYNJ39700B , Lot Number 21DMD882 ; DYNJ39700B , Lot Number 21FMC569 ; DYNJ39700B , Lot Number 21FMF531 ; DYNJ39700B , Lot Number 21GMF302 ; DYNJ39700B , Lot Number 21HMD242 ; DYNJ39700B , Lot Number 21JMH252 ; DYNJ39700B , Lot Number 21KMF491 ; DYNJ39700B , Lot Number 22AMG337 ; DYNJ44109B , Lot Number 21IMF271 ; DYNJ44109B , Lot Number 21JMD783 ; DYNJ44109B , Lot Number 21KME283 ; DYNJ66109A , Lot Number 21JBN809 ; DYNJ66109A , Lot Number 21KBC511 ; DYNJ66109A , Lot Number 22CBP867 ; DYNJ69895, Lot Number 21KBU119 ; DYNJ69895, Lot Number 22EBD392 ; DYNJ69895, Lot Number 22GBH506 ; DYNJ905655A, Lot Number 21ILA013 ; DYNJ905655A, Lot Number 21ILA926 ; DYNJ905655A, Lot Number 21JLB171 ; DYNJ905655A, Lot Number 22ALA375 ; DYNJ905655A, Lot Number 22BLA544 ; DYNJ905655A, Lot Number 22CLB377 ; DYNJ905655A, Lot Number 22ELA391 ; DYNJT2255M , Lot Number 21IMF282 ; DYNJT2255M , Lot Number 21JMC072 ; DYNJT2255M , Lot Number 21JMI117 ; DYNJT2255M , Lot Number 21KMF688 ; DYNJT2255M , Lot Number 21KMG176

Distribution pattern

Worldwide distribution.

device · product 26 of 81

Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ; 7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ; 8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ; 9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ; 10) CYSTO PROCEDURE , Pack Number CDS760062P ; 11) CYSTO PROCEDURE , Pack Number CDS760062Q ; 12) LAPAROSCOPY CDS , Pack Number CDS830216F ; 13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ; 14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ; 15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ; 16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ; 17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ; 18) THOROCOTOMY , Pack Number CDS860040I ; 19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ; 20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ; 21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ; 22) GYN LAP , Pack Number CDS860087K ; 23) GYN LAP , Pack Number CDS860087M ; 24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ; 25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ; 26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ; 27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ; 28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ; 29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ; 30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ; 31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ; 32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ; 33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ; 34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ; 35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ; 36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ; 37) LAPAROSCOPY CDS , Pack Number CDS860194F ; 38) LAPAROSCOPY CDS , Pack Number CDS860194G ; 39) LAPAROSCOPY CDS , Pack Number CDS860194I ; 40) LAPAROSCOPY CDS , Pack Number CDS860229G ; 41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ; 42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ; 43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ; 44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA; 45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB; 46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC; 47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ; 48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ; 49) CYSTO , Pack Number CDS902753F ; 50) LAPAROSCOPIC CDS, Pack Number CDS920043T ; 51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ; 52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ; 53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ; 54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ; 55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ; 56) LAPAROSCOPIC, Pack Number CDS920082X ; 57) LAPAROSCOPIC, Pack Number CDS920082Y ; 58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ; 59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ; 60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ; 61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC; 62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ; 63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ; 64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ; 65) LAP CHOLE CDS-LF, Pack Number CDS930030T ; 66) LAP CHOLE CDS-LF, Pack Number CDS930030U ; 67) LAP CHOLE , Pack Number CDS930089AA; 68) LAP CHOLE CDS , Pack Number CDS930111AA; 69) LAP CHOLE CDS , Pack Number CDS930111AB; 70) LAP CHOLE CDS-LF, Pack Number CDS930117J ; 71) MINOR BASIC-LF, Pack Number CDS930120G ; 72) MINOR BASIC-LF, Pack Number CDS930120I ; 73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ; 74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ; 75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ; 76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ; 77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ; 78)

Z-3006-2024
Recall number
Z-3006-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

7791 , Lot Number 19CDC814 ; 7791 , Lot Number 19EDB234 ; 7791 , Lot Number 19EDC967 ; 7791 , Lot Number 19FDD341 ; 7791 , Lot Number 19GDA594 ; 7791 , Lot Number 19HDC417 ; 7791 , Lot Number 19IDC356 ; 7791 , Lot Number 19KDB323 ; 7791 , Lot Number 19KDB955 ; 7791 , Lot Number 21KDB873 ; 7791 , Lot Number 22CDA330 ; 7791 , Lot Number 22CDA484 ; 7791 , Lot Number 22CDB460 ; CDS760049AC, Lot Number 19KBT844 ; CDS760049AC, Lot Number 20ABJ873 ; CDS760049AC, Lot Number 20BBW737 ; CDS760049AC, Lot Number 20DBL004 ; CDS760049AC, Lot Number 20GBJ882 ; CDS760049AC, Lot Number 20IBH018 ; CDS760049AC, Lot Number 20LBP200 ; CDS760049AC, Lot Number 21ABB006 ; CDS760049AC, Lot Number 21EBA024 ; CDS760049AC, Lot Number 21EBI363 ; CDS760051AB, Lot Number 19ABI119 ; CDS760051AB, Lot Number 19BBP260 ; CDS760051AB, Lot Number 19EBK100 ; CDS760051AB, Lot Number 19EBK170 ; CDS760051AB, Lot Number 19GBH718 ; CDS760051AB, Lot Number 19SBB540 ; CDS760051AB, Lot Number 19SBE251 ; CDS760051AB, Lot Number 19JBP888 ; CDS760051AB, Lot Number 19LBL746 ; CDS760051AC, Lot Number 19WBA844 ; CDS760051AC, Lot Number 19LBY065 ; CDS760051AC, Lot Number 20BBA091 ; CDS760051AC, Lot Number 20BBT794 ; CDS760051AC, Lot Number 20EBU286 ; CDS760051AC, Lot Number 20FBL605 ; CDS760051AC, Lot Number 20GBV069 ; CDS760051AC, Lot Number 20HBO480 ; CDS760051AC, Lot Number 20JBQ421 ; CDS760051AC, Lot Number 20KBL963 ; CDS760051AC, Lot Number 20LBB516 ; CDS760051AC, Lot Number 20LBU992 ; CDS760051AC, Lot Number 21DBV508 ; CDS760051AD, Lot Number 21FBU465 ; CDS760051AD, Lot Number 21HBG002 ; CDS760051AD, Lot Number 21IBP855 ; CDS760051AD, Lot Number 21KBZ599 ; CDS760051AD, Lot Number 21KBZ600 ; CDS760051AD, Lot Number 22DBD548 ; CDS760051AD, Lot Number 22DBG405 ; CDS760051AD, Lot Number 22FBB185 ; CDS760051AD, Lot Number 22FBI490 ; CDS760051AD, Lot Number 22GBD299 ; CDS760051AD, Lot Number 22GBU498 ; CDS760051AD, Lot Number 22IBS739 ; CDS760051AD, Lot Number 22JBF777 ; CDS760051AD, Lot Number 22JBR836 ; CDS760051AD, Lot Number 22KBS068 ; CDS760051AD, Lot Number 23BBG604 ; CDS760051AD, Lot Number 23CBG879 ; CDS760051AD, Lot Number 23FBC729 ; CDS760051AD, Lot Number 23GBD240 ; CDS760051AD, Lot Number 23IBB494 ; CDS760051AD, Lot Number 23IBO569 ; CDS760051AD, Lot Number 23LBE145 ; CDS760051AD, Lot Number 24BBM779 ; CDS760057G , Lot Number 19ABH764 ; CDS760057G , Lot Number 19ABL825 ; CDS760057G , Lot Number 19BBA476 ; CDS760057G , Lot Number 19CBT401 ; CDS760057G , Lot Number 19EBA903 ; CDS760057G , Lot Number 19FBD872 ; CDS760057G , Lot Number 19GBP568 ; CDS760057G , Lot Number 19SBF513 ; CDS760057G , Lot Number 19HBN041 ; CDS760057G , Lot Number 19KBN171 ; CDS760057G , Lot Number 19LBQ707 ; CDS760057G , Lot Number 20BBS579 ; CDS760057G , Lot Number 20OBA112 ; CDS760057I , Lot Number 21FBM605 ; CDS760057I , Lot Number 21HBR385 ; CDS760057I , Lot Number 21IBK118 ; CDS760057I , Lot Number 20EBF638 ; CDS760057I , Lot Number 20GBA315 ; CDS760057I , Lot Number 20HBE854 ; CDS760057I , Lot Number 20IBS984 ; CDS760057I , Lot Number 20KBC976 ; CDS760057I , Lot Number 20LBO858 ; CDS760057I , Lot Number 21BBK105 ; CDS760057I , Lot Number 21CBW931 ; CDS760057I , Lot Number 21EBC903 ; CDS760057J , Lot Number 21JBX790 ; CDS760057J , Lot Number 21LBV289 ; CDS760057J , Lot Number 22NBE608 ; CDS760057J , Lot Number 22OBK791 ; CDS760057J , Lot Number 22DBR270 ; CDS760057J , Lot Number 22FBE976 ; CDS760057J , Lot Number 22FBX954 ; CDS760057J , Lot Number 22HBO176 ; CDS760057J , Lot Number 22HBO511 ; CDS760057K , Lot Number 22LBC409 ; CDS760057K , Lot Number 23ABU244 ; CDS760057K , Lot Number 23CBO552 ; CDS760057K , Lot Number 23CBT750 ; CDS760057K , Lot Number 23EBA183 ; CDS760057K , Lot Number 23EBP896 ; CDS760057K , Lot Number 23GBN928 ; CDS760057K , Lot Number 23IBC604 ; CDS760057K , Lot Number 23JBH987 ; CDS760062P , Lot Number 21FBI200 ; CDS760062P , Lot Number 21HBA510 ; CDS760062P , Lot Number 21IBL982 ; CDS760062P , Lot Number 21KBF471 ; CDS760062P , Lot Number 22BBR315 ; CDS760062P , Lot Number 22BBR316 ; CDS760062P , Lot Number 22OBM499 ; CDS760062P , Lot Number 22GBA062 ; CDS760062P , Lot Number 22IBQ978 ; CDS760062P , Lot Number 22LBE467 ; CDS760062P , Lot Number 23ABU387 ; CDS760062P , Lot Number 23CBP305 ; CDS760062P , Lot Number 23EBG915 ; CDS760062P , Lot Number 23FBU586 ; CDS760062P , Lot Number 23HBN718 ; CDS760062P , Lot Number 21ABU305 ; CDS760062P , Lot Number 21EBE907 ; CDS760062Q , Lot Number 23KBC964 ; CDS760062Q , Lot Number 23LBD670 ; CDS830216F , Lot Number 21FMB272 ; CDS830216F , Lot Number 21FME648 ; CDS830216F , Lot Number 21IMA939 ; CDS830216F , Lot Number 21IMH645 ; CDS830216F , Lot Number 22AMC537 ; CDS830216F , Lot Number 22CME417 ; CDS830216F , Lot Number 22EME098 ; CDS830216F , Lot Number 22HMF279 ; CDS830216F , Lot Number 22IMH576 ; CDS830216F , Lot Number 22LMH113 ; CDS830216F , Lot Number 23AMB967 ; CDS830216F , Lot Number 23AMH591 ; CDS830216F , Lot Number 23BMC494 ; CDS830216F , Lot Number 23BMD518 ; CDS830216F , Lot Number 24AMH917 ; CDS830216F , Lot Number 19CKA634 ; CDS830216F , Lot Number 19EKD500 ; 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CDS920082Y , Lot Number 23JBB056 ; CDS920082Y , Lot Number 23KBH997 ; CDS920082Y , Lot Number 23KBJ531 ; CDS920082Y , Lot Number 24BBH037 ; CDS920082Y , Lot Number 21CBE431 ; CDS920082Y , Lot Number 21EBK850 ; CDS920104F , Lot Number 19BBQ187 ; CDS920104F , Lot Number 19DBX214 ; CDS920104G , Lot Number 21GBS600 ; CDS920104G , Lot Number 21IBK061 ; CDS920104G , Lot Number 21IBK062 ; CDS920104G , Lot Number 21JBQ875 ; CDS920104G , Lot Number 21LBD729 ; CDS920104G , Lot Number 22ABE732 ; CDS920104G , Lot Number 22CBT671 ; CDS920104G , Lot Number 22OBM479 ; CDS920104G , Lot Number 22EBJ539 ; CDS920104G , Lot Number 22EBM258 ; CDS920104G , Lot Number 22FBO301 ; CDS920104G , Lot Number 22FBQ770 ; CDS920104G , Lot Number 22FBR785 ; CDS920104G , Lot Number 19FBQ192 ; CDS920104G , Lot Number 19GBF247 ; CDS920104G , Lot Number 22HBJ364 ; CDS920104G , Lot Number 19IBJ145 ; CDS920104G , Lot Number 22KBP060 ; CDS920104G , Lot Number 22LBC638 ; CDS920104G , Lot Number 19JBE188 ; CDS920104G , Lot Number 23ABM604 ; CDS920104G , Lot Number 19LBC858 ; CDS920104G , Lot Number 23DBD949 ; CDS920104G , Lot Number 20ABP027 ; CDS920104G , Lot Number 23EBV967 ; CDS920104G , Lot Number 20BBK711 ; CDS920104G , Lot Number 23FBB564 ; CDS920104G , Lot Number 23FBS241 ; CDS920104G , Lot Number 20DBF121 ; CDS920104G , Lot Number 20DBQ083 ; CDS920104G , Lot Number 23HBY251 ; CDS920104G , Lot Number 20FBI378 ; CDS920104G , Lot Number 20IBG102 ; CDS920104G , Lot Number 21BBN524 ; CDS920104G , Lot Number 21CBI437 ; CDS920104G , Lot Number 21FBB108 ; CDS920104I , Lot Number 23KBC703 ; CDS920104I , Lot Number 24ABI142 ; CDS920104I , Lot Number 24ABN324 ; CDS920126AC, Lot Number 23EMI777 ; CDS920126AC, Lot Number 23FMG082 ; CDS920126AC, Lot Number 23HMF743 ; CDS920126AC, Lot Number 23HMH041 ; CDS920126AC, Lot Number 23JMF264 ; CDS920126AC, Lot Number 23LMA927 ; CDS930027T , Lot Number 19BBA759 ; CDS930027T , Lot Number 19CBM946 ; CDS930027T , Lot Number 19EBM805 ; CDS930027T , Lot Number 19RBC090 ; CDS930027T , Lot Number 19IBU719 ; CDS930027T , Lot Number 19VBH003 ; CDS930027T , Lot Number 20ABS564 ; CDS930027T , Lot Number 20CBF531 ; CDS930027U , Lot Number 21GBV752 ; CDS930027U , Lot Number 21HBK319 ; CDS930027U , Lot Number 21IBR168 ; CDS930027U , Lot Number 22CBK058 ; CDS930027U , Lot Number 22OBH011 ; CDS930027U , Lot Number 22OBJ669 ; CDS930027U , Lot Number 22FBY534 ; CDS930027U , Lot Number 22GBO449 ; CDS930027U , Lot Number 20DBK860 ; CDS930027U , Lot Number 20EBG195 ; CDS930027U , Lot Number 20GBD826 ; CDS930027U , Lot Number 20GBS045 ; CDS930027U , Lot Number 20IBD319 ; CDS930027U , Lot Number 20IBL503 ; CDS930027U , Lot Number 20LBP534 ; CDS930027U , Lot Number 21BBC629 ; CDS930027U , Lot Number 21DBG141 ; CDS930027V , Lot Number 22JBJ699 ; CDS930027V , Lot Number 22JBR529 ; CDS930027V , Lot Number 23ABL590 ; CDS930027V , Lot Number 23CBP730 ; CDS930027V , Lot Number 23EBA579 ; CDS930027V , Lot Number 23FBV023 ; CDS930027V , Lot Number 23IBL080 ; CDS930027V , Lot Number 23IBL168 ; CDS930027V , Lot Number 23KBK362 ; CDS930027V , Lot Number 23KBW155 ; CDS930030T , Lot Number 19BBA573 ; CDS930030T , Lot Number 19CBK509 ; CDS930030T , Lot Number 19DBV654 ; CDS930030T , Lot Number 19FBM121 ; CDS930030T , Lot Number 19GBM872 ; CDS930030T , Lot Number 19TBC908 ; CDS930030T , Lot Number 19JBX099 ; CDS930030T , Lot Number 19KBZ809 ; CDS930030T , Lot Number 19LBU162 ; CDS930030T , Lot Number 20CBL945 ; CDS930030T , Lot Number 20DBD766 ; CDS930030T , Lot Number 20EBO466 ; CDS930030T , Lot Number 20GBB536 ; CDS930030U , Lot Number 20KBT203 ; CDS930030U , Lot Number 21BBG083 ; CDS930030U , Lot Number 21CBJ270 ; CDS930030U , Lot Number 21DBU055 ; CDS930089AA, Lot Number 21GBU903 ; CDS930089AA, Lot Number 21HBL112 ; CDS930089AA, Lot Number 21LBF061 ; CDS930089AA, Lot Number 22ABA351 ; CDS930089AA, Lot Number 22ABT863 ; CDS930089AA, Lot Number 19BBI392 ; CDS930089AA, Lot Number 22CBZ082 ; CDS930089AA, Lot Number 22OBI153 ; CDS930089AA, Lot Number 19CBO430 ; CDS930089AA, Lot Number 19PBB793 ; CDS930089AA, Lot Number 22FBR220 ; CDS930089AA, Lot Number 22GBM173 ; CDS930089AA, Lot Number 19FBT057 ; CDS930089AA, Lot Number 19HBV784 ; CDS930089AA, Lot Number 19IBZ336 ; CDS930089AA, Lot Number 22LBG829 ; CDS930089AA, Lot Number 23ABM683 ; CDS930089AA, Lot Number 19VBF797 ; CDS930089AA, Lot Number 19LBU147 ; CDS930089AA, Lot Number 23DBQ286 ; CDS930089AA, Lot Number 20BBB545 ; CDS930089AA, Lot Number 23FBC727 ; CDS930089AA, Lot Number 23FBU034 ; CDS930089AA, Lot Number 23GBN307 ; CDS930089AA, Lot Number 20CBW907 ; CDS930089AA, Lot Number 20EBE543 ; CDS930089AA, Lot Number 20EBI717 ; CDS930089AA, Lot Number 23JBD587 ; CDS930089AA, Lot Number 20GBB110 ; CDS930089AA, Lot Number 20GBJ929 ; CDS930089AA, Lot Number 23KBH971 ; CDS930089AA, Lot Number 23LBF456 ; CDS930089AA, Lot Number 20JBD444 ; CDS930089AA, Lot Number 20JBM306 ; CDS930089AA, Lot Number 21BBS512 ; CDS930089AA, Lot Number 21DBP220 ; CDS930089AA, Lot Number 21EBK873 ; CDS930111AA, Lot Number 20ABL112 ; CDS930111AA, Lot Number 20CBC241 ; CDS930111AA, Lot Number 20GBB526 ; CDS930111AA, Lot Number 20HBO487 ; CDS930111AA, Lot Number 20LBS202 ; CDS930111AA, Lot Number 21CBP654 ; CDS930111AB, Lot Number 21IBJ205 ; CDS930111AB, Lot Number 21IBK117 ; CDS930111AB, Lot Number 21IBW760 ; CDS930111AB, Lot Number 21JBF950 ; CDS930111AB, Lot Number 21KBI384 ; CDS930111AB, Lot Number 21LBV273 ; CDS930111AB, Lot Number 22BBN366 ; CDS930111AB, Lot Number 22CBX116 ; CDS930111AB, Lot Number 22OBM495 ; CDS930111AB, Lot Number 22EBK391 ; CDS930111AB, Lot Number 22FBS263 ; CDS930111AB, Lot Number 22HBS336 ; CDS930111AB, Lot Number 22JBP072 ; CDS930111AB, Lot Number 22KBN952 ; CDS930111AB, Lot Number 23ABS830 ; CDS930111AB, Lot Number 23DBE031 ; CDS930111AB, Lot Number 23FBA347 ; CDS930111AB, Lot Number 23GBV748 ; CDS930111AB, Lot Number 23HBY074 ; CDS930111AB, Lot Number 23JBW674 ; CDS930111AB, Lot Number 24ABB946 ; CDS930117J , Lot Number 21FBJ128 ; CDS930117J , Lot Number 21HBC602 ; CDS930117J , Lot Number 21KBF379 ; CDS930117J , Lot Number 21LBC688 ; CDS930117J , Lot Number 22MBA147 ; CDS930117J , Lot Number 19ABV527 ; CDS930117J , Lot Number 19CBA601 ; CDS930117J , Lot Number 22OBB425 ; CDS930117J , Lot Number 22OBJ624 ; CDS930117J , Lot Number 19DBD054 ; CDS930117J , Lot Number 19EBH984 ; CDS930117J , Lot Number 22FBG748 ; CDS930117J , Lot Number 22FBN280 ; CDS930117J , Lot Number 19FBN226 ; CDS930117J , Lot Number 22GBS430 ; CDS930117J , Lot Number 22HBO683 ; CDS930117J , Lot Number 19HBW390 ; CDS930117J , Lot Number 22JBL434 ; CDS930117J , Lot Number 22LBH539 ; CDS930117J , Lot Number 23ABD136 ; CDS930117J , Lot Number 19VBF652 ; CDS930117J , Lot Number 19LBE159 ; CDS930117J , Lot Number 20BBE291 ; CDS930117J , Lot Number 20DBB687 ; CDS930117J , Lot Number 20FBJ067 ; CDS930117J , Lot Number 20HBG826 ; CDS930117J , Lot Number 20JBU664 ; CDS930117J , Lot Number 20LBG120 ; CDS930117J , Lot Number 21CBI120 ; CDS930120G , Lot Number 21JBX687 ; CDS930120G , Lot Number 21KBO560 ; CDS930120G , Lot Number 21LBI714 ; CDS930120G , Lot Number 22OBD872 ; CDS930120G , Lot Number 22FBF472 ; CDS930120G , Lot Number 22FBV562 ; CDS930120G , Lot Number 22HBE369 ; CDS930120G , Lot Number 22HBS333 ; CDS930120G , Lot Number 22IBU622 ; CDS930120G , Lot Number 22JBG904 ; CDS930120G , Lot Number 22JBL442 ; CDS930120G , Lot Number 22KBI260 ; CDS930120G , Lot Number 22LBT330 ; CDS930120G , Lot Number 23ABQ984 ; CDS930120G , Lot Number 23BBG709 ; CDS930120G , Lot Number 23EBD647 ; CDS930120G , Lot Number 23HBS779 ; CDS930120G , Lot Number 23HBS920 ; CDS930120G , Lot Number 23JBJ078 ; CDS930120I , Lot Number 23KBP659 ; CDS930125R , Lot Number 19ABX208 ; CDS930125R , Lot Number 19BBU623 ; CDS930125R , Lot Number 19PBB795 ; CDS930125R , Lot Number 19FBO219 ; CDS930125R , Lot Number 19TBC174 ; CDS930125R , Lot Number 19IBE433 ; CDS930125R , Lot Number 19JBT783 ; CDS930125R , Lot Number 19KBH808 ; CDS930125R , Lot Number 19LBL963 ; CDS930125R , Lot Number 20ABZ988 ; CDS930125R , Lot Number 20CBF694 ; CDS930125R , Lot Number 20DBB574 ; CDS930125R , Lot Number 20EBM625 ; CDS930125R , Lot Number 20EBO407 ; CDS930125S , Lot Number 20HBJ896 ; CDS930125T , Lot Number 21FBP666 ; CDS930125T , Lot Number 21HBK248 ; CDS930125T , Lot Number 21HBV013 ; CDS930125T , Lot Number 21ABO338 ; CDS930125T , Lot Number 21CBD702 ; CDS930125T , Lot Number 21DBT977 ; CDS930125T , Lot Number 21EBO614 ; CDS930125U , Lot Number 22ABW424 ; CDS930125U , Lot Number 22DBS504 ; CDS930125U , Lot Number 22FBV303 ; CDS930125U , Lot Number 22GBU110 ; CDS930125V , Lot Number 22JBA038 ; CDS930125V , Lot Number 22JBH334 ; CDS930125V , Lot Number 23BBA847 ; CDS930125V , Lot Number 23BBA853 ; CDS930125V , Lot Number 23BBG453 ; CDS930125V , Lot Number 23DBE116 ; CDS930125V , Lot Number 23GBJ662 ; CDS930125V , Lot Number 23HBL229 ; CDS930125V , Lot Number 23JBB241 ; CDS930137G , Lot Number 19BBU032 ; CDS930161C , Lot Number 21IBG798 ; CDS930161C , Lot Number 21KBH053 ; CDS930161C , Lot Number 22ABC108 ; CDS930161C , Lot Number 19ABP758 ; CDS930161C , Lot Number 19BBS825 ; CDS930161C , Lot Number 19DBO528 ; CDS930161C , Lot Number 22EBN080 ; CDS930161C , Lot Number 19EBR982 ; CDS930161C , Lot Number 22GBP737 ; CDS930161C , Lot Number 19FBZ168 ; CDS930161C , Lot Number 19VBA661 ; CDS930161C , Lot Number 20ABI300 ; CDS930161C , Lot Number 20ABX988 ; CDS930161C , Lot Number 20CBA339 ; CDS930161C , Lot Number 20DBD796 ; CDS930161C , Lot Number 20EBO424 ; CDS930161C , Lot Number 20FBR036 ; CDS930161C , Lot Number 20GBQ391 ; CDS930161C , Lot Number 20VBB224 ; CDS930161C , Lot Number 20KBL968 ; CDS930161C , Lot Number 21DBS567 ; CDS930161C , Lot Number 21EBE941 ; CDS930161C , Lot Number 21EBQ935 ; CDS930161C , Lot Number 22IMD546 ; CDS930161C , Lot Number 23AMF086 ; CDS930161C , Lot Number 23FMI179 ; CDS930161C , Lot Number 23GMI714 ; CDS930161D , Lot Number 23KMH438 ; CDS930161D , Lot Number 24AMH879 ; CDS930191R , Lot Number 19ABX734 ; CDS930191R , Lot Number 19BBL857 ; CDS930191R , Lot Number 19CBJ262 ; CDS930191R , Lot Number 19PBB306 ; CDS930191S , Lot Number 19FBA457 ; CDS930191T , Lot Number 19HBH294 ; CDS930191T , Lot Number 19IBY458 ; CDS930191T , Lot Number 19VBF320 ; CDS930191T , Lot Number 19LBN303 ; CDS930191T , Lot Number 19LBY064 ; CDS930191T , Lot Number 20CBJ831 ; CDS930191T , Lot Number 20DBB180 ; CDS930191T , Lot Number 20DBD283 ; CDS930191T , Lot Number 20

Distribution pattern

Worldwide distribution.

device · product 27 of 81

Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number DYNDC3274; 6) MYELOGRAM TRAY, Pack Number DYNDH1531; 7) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 8) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 9) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 10) LUMBAR PUNCTURE TRAY, Pack Number PT215; 11) FINE LACERATION KIT, Pack Number SUT19360

Z-3007-2024
Recall number
Z-3007-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CVI4830A, Lot Number 2022072850; CVI4835, Lot Number 2022061350; CVI4835, Lot Number 2022072850; CVI4835, Lot Number 2023111490; CVI4835, Lot Number 2023112790; DT18185, Lot Number 23EBS508 ; DT18185, Lot Number 23FBU960 ; DT18185, Lot Number 23HBQ339 ; DT22005, Lot Number 21JBI227 ; DYNDC3274, Lot Number 2022111490; DYNDC3274, Lot Number 2023101190; DYNDC3274, Lot Number 2023112790; DYNDH1531, Lot Number 2022111490; DYNJTS4301, Lot Number 2022061350; DYNJTS4301, Lot Number 2022061350; DYNJTS4306, Lot Number 2022061350; DYNJTS8100, Lot Number 2022061350; PT215, Lot Number 2022061350; SUT19360, Lot Number 2022111490

Distribution pattern

Worldwide distribution.

device · product 28 of 81

Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I

Z-3008-2024
Recall number
Z-3008-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS984309I, Lot Number 22DBK534

Distribution pattern

Worldwide distribution.

device · product 29 of 81

Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCOPY KIT , Pack Number DYKE1389 ; 7) ENDO KIT, Pack Number DYKE1856 ; 8) WCH ENDO KIT, Pack Number DYKE1864B; 9) ENDO PACK , Pack Number DYNDA3058; 10) ENDOSCOPY PACK-LF , Pack Number DYNJ00339J ; 11) TR-ENT ENDO PACK-LF , Pack Number DYNJ0396027I ; 12) ENDOSCOPIC CHOLE PACK-LF, Pack Number DYNJ0426277J ; 13) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661L ; 14) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661O ; 15) ENDOSCOPY-LF, Pack Number DYNJ22890L ; 16) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G ; 17) ENDOSCOPY PACK, Pack Number DYNJ50594C ; 18) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221B ; 19) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221C ; 20) ENDOSCOPIC PACK , Pack Number DYNJ54221J ; 21) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478B ; 22) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478D ; 23) ENDO PACK , Pack Number DYNJ56043B ; 24) ENDO PACK , Pack Number DYNJ56043C ; 25) ENDO PACK, Pack Number DYNJ56043F; 26) ENDO PACK , Pack Number DYNJ56043F ; 27) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648B ; 28) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648C ; 29) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648D ; 30) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648J ; 31) ENDO / AUG PACK , Pack Number DYNJ59250A ; 32) ENDO / AUG PACK , Pack Number DYNJ59250B ; 33) PACK ENDO AAA HYBRIDCHRG, Pack Number DYNJ60126B ; 34) DIPASCO GENERAL ENDOCRINE PACK, Pack Number DYNJ60686A ; 35) ENDOSCOPIC PACK , Pack Number DYNJ63797; 36) ENDOSCOPY PACK, Pack Number DYNJ65524; 37) GENERAL ENDOSCOPIC PK , Pack Number DYNJ66034A ; 38) ENT ENDO SINUS WILMINGTON PACK, Pack Number DYNJ66447; 39) ENDOVENOUS PACK , Pack Number DYNJ66596; 40) GENERAL ENDOSCOPIC PACK , Pack Number DYNJ67382B ; 41) PEDI ENDO LAP PACK, Pack Number DYNJ68141; 42) GEN ENDOSCOPY , Pack Number DYNJ81490; 43) PACK ENDOSCOPIC CHOLECYSTE, Pack Number DYNJ81539; 44) ENDO UROLOGY, Pack Number DYNJ83704A ; 45) ENDOSCOPY , Pack Number DYNJ900509N; 46) ENDOSCOPY , Pack Number DYNJ900509O; 47) ENDO OMH, Pack Number DYNJ900525C; 48) MODULE ENDO LAP , Pack Number DYNJ903026F; 49) MODULE ENDO LAP , Pack Number DYNJ903026G; 50) GENERAL ENDOSCOPY , Pack Number DYNJ903421D; 51) CYSTO , Pack Number DYNJ903521A; 52) GENERAL ENDOSCOPY , Pack Number DYNJ903826F; 53) ENDO, Pack Number DYNJ904836A; 54) ENDO, Pack Number DYNJ904836B; 55) ENDO, Pack Number DYNJ904836C; 56) ENDO, Pack Number DYNJ904836D; 57) DIPASCO GENERAL ENDOCRINE , Pack Number DYNJ906574 ; 58) ENDOSCOPIC SKULL BASE , Pack Number DYNJ908362B; 59) ENDOSCOPY KIT , Pack Number P830355A ; 60) ENDOSCOPY KIT , Pack Number P830355AH

Z-3009-2024
Recall number
Z-3009-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS981309O , Lot Number 19GBS426 ; CDS981309O , Lot Number 19JBE731 ; CDS981309O , Lot Number 19LBN327 ; CDS981309O , Lot Number 20BBE553 ; CDS981309O , Lot Number 20DBG947 ; CDS981309O , Lot Number 20GBU396 ; CDS984155F , Lot Number 19GBV870 ; CDS984155F , Lot Number 19JBX096 ; DYKE1112 , Lot Number 23LME611 ; DYKE1133A, Lot Number 22AMA243 ; DYKE1264 , Lot Number 22GME430 ; DYKE1264 , Lot Number 22HMA299 ; DYKE1389 , Lot Number 19DBL730 ; DYKE1389 , Lot Number 19DBN769 ; DYKE1389 , Lot Number 19VBA308 ; DYKE1389 , Lot Number 19KBI635 ; DYKE1389 , Lot Number 20ABU603 ; DYKE1856 , Lot Number 22JBU738 ; DYKE1856 , Lot Number 22LBC945 ; DYKE1856 , Lot Number 23ABJ226 ; DYKE1864B, Lot Number 23LBG919 ; DYNDA3058, Lot Number 23GBJ275 ; DYNDA3058, Lot Number 23JBJ971 ; DYNDA3058, Lot Number 23LBA980 ; DYNJ00339J , Lot Number 19LMB920 ; DYNJ00339J , Lot Number 20BMA093 ; DYNJ00339J , Lot Number 19DKA281 ; DYNJ00339J , Lot Number 19DKC903 ; DYNJ00339J , Lot Number 19GKA519 ; DYNJ00339J , Lot Number 19JKB148 ; DYNJ0396027I , Lot Number 19DDA509 ; DYNJ0426277J , Lot Number 19IMB754 ; DYNJ0426277J , Lot Number 20AMA124 ; DYNJ0426277J , Lot Number 20CMC692 ; DYNJ0426277J , Lot Number 20FMB816 ; DYNJ0426277J , Lot Number 20HMB568 ; DYNJ0426277J , Lot Number 20IMD473 ; DYNJ0426277J , Lot Number 21AMB951 ; DYNJ0426277J , Lot Number 21CMC718 ; DYNJ0426277J , Lot Number 21FMB061 ; DYNJ0426277J , Lot Number 19HKC356 ; DYNJ22661L , Lot Number 19HBO860 ; DYNJ22661L , Lot Number 19IBM436 ; DYNJ22661L , Lot Number 19JBQ066 ; DYNJ22661L , Lot Number 19KBK813 ; DYNJ22661L , Lot Number 19LBU575 ; DYNJ22661L , Lot Number 20BBX496 ; DYNJ22661L , Lot Number 20DBB020 ; DYNJ22661L , Lot Number 20GMC054 ; DYNJ22661L , Lot Number 20IMA806 ; DYNJ22661L , Lot Number 20IMC442 ; DYNJ22661L , Lot Number 20KMA517 ; DYNJ22661L , Lot Number 20LMF851 ; DYNJ22661L , Lot Number 21CMC664 ; DYNJ22661L , Lot Number 21HMA104 ; DYNJ22661L , Lot Number 21HMD574 ; DYNJ22661L , Lot Number 21IME853 ; DYNJ22661O , Lot Number 23GMB192 ; DYNJ22661O , Lot Number 23HMD182 ; DYNJ22661O , Lot Number 23IMG591 ; DYNJ22890L , Lot Number 19DBH535 ; DYNJ22890L , Lot Number 19EBT736 ; DYNJ22890L , Lot Number 19FBX264 ; DYNJ44673G , Lot Number 22IDB664 ; DYNJ44673G , Lot Number 22JDB619 ; DYNJ44673G , Lot Number 22KDB136 ; DYNJ44673G , Lot Number 22KDC145 ; DYNJ44673G , Lot Number 22LDA396 ; DYNJ44673G , Lot Number 23CDC115 ; DYNJ44673G , Lot Number 23DDB896 ; DYNJ44673G , Lot Number 23EDB560 ; DYNJ44673G , Lot Number 23GDB181 ; DYNJ44673G , Lot Number 23KDA313 ; DYNJ44673G , Lot Number 24ADA583 ; DYNJ44673G , Lot Number 24ADB767 ; DYNJ44673G , Lot Number 24BDB676 ; DYNJ50594C , Lot Number 19IBX922 ; DYNJ50594C , Lot Number 19JBY497 ; DYNJ50594C , Lot Number 20CBA891 ; DYNJ50594C , Lot Number 20DBQ243 ; DYNJ50594C , Lot Number 20EBR005 ; DYNJ50594C , Lot Number 20HBB011 ; DYNJ50594C , Lot Number 20HBM366 ; DYNJ50594C , Lot Number 21ABG167 ; DYNJ50594C , Lot Number 21BBN822 ; DYNJ50594C , Lot Number 21CBE742 ; DYNJ54221B , Lot Number 19RBA244 ; DYNJ54221B , Lot Number 19GBS216 ; DYNJ54221B , Lot Number 19HBJ331 ; DYNJ54221B , Lot Number 19HBL555 ; DYNJ54221C , Lot Number 19JBQ044 ; DYNJ54221C , Lot Number 19KBB653 ; DYNJ54221C , Lot Number 19LBS870 ; DYNJ54221C , Lot Number 20ABU331 ; DYNJ54221C , Lot Number 20BBL702 ; DYNJ54221C , Lot Number 20EBE847 ; DYNJ54221C , Lot Number 20EBK160 ; DYNJ54221J , Lot Number 23HBL781 ; DYNJ54221J , Lot Number 23JBW829 ; DYNJ54221J , Lot Number 23LBF338 ; DYNJ55478B , Lot Number 21GBP757 ; DYNJ55478B , Lot Number 21JBO286 ; DYNJ55478B , Lot Number 21JBO302 ; DYNJ55478B , Lot Number 21LBD900 ; DYNJ55478B , Lot Number 21LBS328 ; DYNJ55478B , Lot Number 22ABL817 ; DYNJ55478B , Lot Number 22ABU347 ; DYNJ55478B , Lot Number 19ABF658 ; DYNJ55478B , Lot Number 22BBT857 ; DYNJ55478B , Lot Number 19BBS313 ; DYNJ55478B , Lot Number 22OBG299 ; DYNJ55478B , Lot Number 22OBJ730 ; DYNJ55478B , Lot Number 22EBL784 ; DYNJ55478B , Lot Number 19EBA365 ; DYNJ55478B , Lot Number 19GBH857 ; DYNJ55478B , Lot Number 19HBL661 ; DYNJ55478B , Lot Number 19JBX017 ; DYNJ55478B , Lot Number 19LBG025 ; DYNJ55478B , Lot Number 20CBE081 ; DYNJ55478B , Lot Number 20CBM750 ; DYNJ55478B , Lot Number 20DBQ209 ; DYNJ55478B , Lot Number 20EBO179 ; DYNJ55478B , Lot Number 21EBP478 ; DYNJ55478B , Lot Number 21EBP489 ; DYNJ55478D , Lot Number 23DBH240 ; DYNJ55478D , Lot Number 23FBQ176 ; DYNJ55478D , Lot Number 23HBE122 ; DYNJ55478D , Lot Number 23IBT533 ; DYNJ55478D , Lot Number 23KBW864 ; DYNJ56043B , Lot Number 19FBW687 ; DYNJ56043B , Lot Number 19RBC753 ; DYNJ56043B , Lot Number 19HBD919 ; DYNJ56043C , Lot Number 19UBA723 ; DYNJ56043C , Lot Number 19KBS706 ; DYNJ56043C , Lot Number 19LBN154 ; DYNJ56043C , Lot Number 20BBR424 ; DYNJ56043C , Lot Number 20CBG391 ; DYNJ56043C , Lot Number 20EBH068 ; DYNJ56043C , Lot Number 20FBN679 ; DYNJ56043C , Lot Number 20HBB551 ; DYNJ56043C , Lot Number 20JBN241 ; DYNJ56043C , Lot Number 20KBK445 ; DYNJ56043F, Lot Number 24BMB676; DYNJ56043F , Lot Number 23JMA380 ; DYNJ56043F , Lot Number 23LMA604 ; DYNJ58648B , Lot Number 19BDB193 ; DYNJ58648C , Lot Number 19EDD585 ; DYNJ58648C , Lot Number 19IDA770 ; DYNJ58648C , Lot Number 20AMA033 ; DYNJ58648C , Lot Number 20AMC750 ; DYNJ58648C , Lot Number 20EMB449 ; DYNJ58648D , Lot Number 20KMC595 ; DYNJ58648D , Lot Number 21AMB129 ; DYNJ58648J , Lot Number 22KMD675 ; DYNJ58648J , Lot Number 23DMD129 ; DYNJ58648J , Lot Number 23HMG766 ; DYNJ58648J , Lot Number 23JMD938 ; DYNJ59250A , Lot Number 19IBG556 ; DYNJ59250A , Lot Number 19JBB091 ; DYNJ59250B , Lot Number 20ABS111 ; DYNJ59250B , Lot Number 20EBR009 ; DYNJ59250B , Lot Number 20FBA296 ; DYNJ59250B , Lot Number 20GMD049 ; DYNJ59250B , Lot Number 20HMD501 ; DYNJ59250B , Lot Number 20IMC499 ; DYNJ59250B , Lot Number 20JMD902 ; DYNJ59250B , Lot Number 20LMB819 ; DYNJ59250B , Lot Number 21AMD112 ; DYNJ59250B , Lot Number 21BMD535 ; DYNJ59250B , Lot Number 21CMB360 ; DYNJ59250B , Lot Number 21EMA212 ; DYNJ59250B , Lot Number 21FMA715 ; DYNJ60126B , Lot Number 22DMC817 ; DYNJ60126B , Lot Number 22FME975 ; DYNJ60126B , Lot Number 22IMG387 ; DYNJ60126B , Lot Number 22KMA517 ; DYNJ60126B , Lot Number 23BMC940 ; DYNJ60126B , Lot Number 23BMI394 ; DYNJ60126B , Lot Number 23CMF847 ; DYNJ60126B , Lot Number 23DMF461 ; DYNJ60126B , Lot Number 23EMF694 ; DYNJ60126B , Lot Number 23JMI216 ; DYNJ60126B , Lot Number 23KMF321 ; DYNJ60126B , Lot Number 23KMJ544 ; DYNJ60686A , Lot Number 19HBA763 ; DYNJ63797, Lot Number 19HBP133 ; DYNJ65524, Lot Number 20CBX808 ; DYNJ65524, Lot Number 20GBT243 ; DYNJ65524, Lot Number 20IBJ954 ; DYNJ65524, Lot Number 21ABP007 ; DYNJ66034A , Lot Number 22FBE056 ; DYNJ66034A , Lot Number 22HBT057 ; DYNJ66034A , Lot Number 22JBI274 ; DYNJ66034A , Lot Number 22JBY015 ; DYNJ66034A , Lot Number 22LBP732 ; DYNJ66034A , Lot Number 23ABL743 ; DYNJ66034A , Lot Number 23CBL351 ; DYNJ66034A , Lot Number 23CBW295 ; DYNJ66034A , Lot Number 23EBT384 ; DYNJ66034A , Lot Number 23EBT758 ; DYNJ66034A , Lot Number 23GBJ043 ; DYNJ66034A , Lot Number 23HBQ666 ; DYNJ66034A , Lot Number 23IBW230 ; DYNJ66034A , Lot Number 23JBX037 ; DYNJ66034A , Lot Number 23LBU935 ; DYNJ66447, Lot Number 21JBO555 ; DYNJ66447, Lot Number 21KBC098 ; DYNJ66447, Lot Number 21KBV126 ; DYNJ66447, Lot Number 21LBP144 ; DYNJ66447, Lot Number 22DBO407 ; DYNJ66447, Lot Number 22DBO928 ; DYNJ66447, Lot Number 22HBR972 ; DYNJ66447, Lot Number 22JBF016 ; DYNJ66447, Lot Number 23JBM687 ; DYNJ66447, Lot Number 23LBN206 ; DYNJ66596, Lot Number 20GBI925 ; DYNJ67382B , Lot Number 23EMF017 ; DYNJ67382B , Lot Number 23GMC927 ; DYNJ67382B , Lot Number 23HMC443 ; DYNJ67382B , Lot Number 23IME008 ; DYNJ67382B , Lot Number 23JMH559 ; DYNJ67382B , Lot Number 23LMC243 ; DYNJ68141, Lot Number 21CBK909 ; DYNJ68141, Lot Number 21DBJ222 ; DYNJ81490, Lot Number 22EBG821 ; DYNJ81490, Lot Number 22HBG106 ; DYNJ81490, Lot Number 22HBY318 ; DYNJ81490, Lot Number 22KBP817 ; DYNJ81490, Lot Number 23BBF609 ; DYNJ81539, Lot Number 22HBR010 ; DYNJ81539, Lot Number 22LBQ876 ; DYNJ81539, Lot Number 23ABU720 ; DYNJ81539, Lot Number 23CBI016 ; DYNJ83704A , Lot Number 23FMF339 ; DYNJ83704A , Lot Number 23HME942 ; DYNJ83704A , Lot Number 23HMF394 ; DYNJ83704A , Lot Number 23HMF701 ; DYNJ900509N, Lot Number 22JBW691 ; DYNJ900509N, Lot Number 22LBG812 ; DYNJ900509N, Lot Number 23ABM561 ; DYNJ900509N, Lot Number 23BBR703 ; DYNJ900509O, Lot Number 23FBK476 ; DYNJ900509O, Lot Number 23HBX994 ; DYNJ900509O, Lot Number 23IBN416 ; DYNJ900509O, Lot Number 23JBT820 ; DYNJ900509O, Lot Number 23KBP934 ; DYNJ900525C, Lot Number 19KBI868 ; DYNJ900525C, Lot Number 20BBI322 ; DYNJ900525C, Lot Number 20CBO862 ; DYNJ903026F, Lot Number 20BBK717 ; DYNJ903026F, Lot Number 20CBX723 ; DYNJ903026G, Lot Number 20DBT281 ; DYNJ903026G, Lot Number 20FBA151 ; DYNJ903026G, Lot Number 20FBT932 ; DYNJ903026G, Lot Number 20HBG899 ; DYNJ903026G, Lot Number 20IBS987 ; DYNJ903026G, Lot Number 20KBJ534 ; DYNJ903421D, Lot Number 19EBI945 ; DYNJ903421D, Lot Number 19FBN494 ; DYNJ903421D, Lot Number 19HBG628 ; DYNJ903421D, Lot Number 19HBM256 ; DYNJ903421D, Lot Number 19JBX085 ; DYNJ903421D, Lot Number 19LBB732 ; DYNJ903421D, Lot Number 20ABP122 ; DYNJ903421D, Lot Number 20CBC110 ; DYNJ903421D, Lot Number 20EBA325 ; DYNJ903421D, Lot Number 20FBG639 ; DYNJ903421D, Lot Number 20GBR856 ; DYNJ903421D, Lot Number 20IBB212 ; DYNJ903521A, Lot Number 19BBR865 ; DYNJ903521A, Lot Number 19CBT729 ; DYNJ903521A, Lot Number 19GBA961 ; DYNJ903521A, Lot Number 19VBE306 ; DYNJ903521A, Lot Number 20BBD187 ; DYNJ903826F, Lot Number 23ABJ844 ; DYNJ903826F, Lot Number 23ABS418 ; DYNJ903826F, Lot Number 23BBR653 ; DYNJ904836A, Lot Number 19CBF679 ; DYNJ904836A, Lot Number 19DBT189 ; DYNJ904836A, Lot Number 19FBM782 ; DYNJ904836A, Lot Number 19GBA138 ; DYNJ904836A, Lot Number 19IBA466 ; DYNJ904836A, Lot Number 19IBQ912 ; DYNJ904836A, Lot Number 19KBK072 ; DYNJ904836A, Lot Number 19LBP264 ; DYNJ904836A, Lot Number 20BBC548 ; DYNJ904836B, Lot Number 20ABM050 ; DYNJ904836B, Lot Number 20CBB774 ; DYNJ904836C, Lot Number 20CBU472 ; DYNJ904836D, Lot Number 20FBF337 ; DYNJ904836D, Lot Number 20IBD212 ; DYNJ904836D, Lot Number 20JBD003 ; DYNJ904836D, Lot Number 20JBD122 ; DYNJ904836D, Lot Number 20JBX884 ; DYNJ906574 , Lot Number 20CBH955 ; DYNJ906574 , Lot Number 20EBU071 ; DYNJ906574 , Lot Number 20FBB155 ; DYNJ906574 , Lot Number 20FBJ594 ; DYNJ906574 , Lot Number 20FBO709 ; DYNJ906574 , Lot Number 20FBP489 ; DYNJ906574 , Lot Number 20FBU277 ; DYNJ906574 , Lot Number 20GBB134 ; DYNJ906574 , Lot Number 20HBN043 ; DYNJ908362B, Lot Number 23FLA515 ; DYNJ908362B, Lot Number 23HLA926 ; DYNJ908362B, Lot Number 23ILA611 ; DYNJ908362B, Lot Number 23JLA551 ; DYNJ908362B, Lot Number 23KLA222 ; DYNJ908362B, Lot Number 23LLA801 ; P830355A , Lot Number 23LME416 ; P830355AH, Lot Number 23LME416

Distribution pattern

Worldwide distribution.

device · product 30 of 81

Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number DYNJ45882A ; 6) TONSIL PACK CATH, Pack Number DYNJ65199A ; 7) CATH PLACEMENT RIB FRACTURE , Pack Number DYNJ66475B ; 8) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211C ; 9) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211CH; 10) UROLOGY PK, Pack Number DYNJ80252C ; 11) PORT INSERTION PACK , Pack Number DYNJ81597

Z-3010-2024
Recall number
Z-3010-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CVI4720A , Lot Number 23DLA715 ; CVI4720A , Lot Number 23ELB184 ; CVI4720A , Lot Number 23GLA187 ; CVI4720A , Lot Number 23ILA599 ; CVI4720A , Lot Number 23ILA949 ; CVI4720A , Lot Number 23JLA318 ; CVI4720A , Lot Number 23JLB102 ; CVI4720AH, Lot Number 23DLA715 ; CVI4720AH, Lot Number 23ELB184 ; CVI4720AH, Lot Number 23GLA187 ; CVI4720AH, Lot Number 23ILA599 ; CVI4720AH, Lot Number 23ILA949 ; CVI4720AH, Lot Number 23JLA318 ; CVI4720AH, Lot Number 23JLB102 ; CVI4880, Lot Number 22LBM567 ; CVI4880, Lot Number 23HBU762 ; DYNJ17634D , Lot Number 23LBB611 ; DYNJ45882A , Lot Number 21HBE710 ; DYNJ45882A , Lot Number 21HBO631 ; DYNJ45882A , Lot Number 21JBD536 ; DYNJ45882A , Lot Number 21VBB891 ; DYNJ45882A , Lot Number 22ABC436 ; DYNJ45882A , Lot Number 19ABG982 ; DYNJ45882A , Lot Number 22CBJ819 ; DYNJ45882A , Lot Number 19BBO164 ; DYNJ45882A , Lot Number 19PBB128 ; DYNJ45882A , Lot Number 19EBS629 ; DYNJ45882A , Lot Number 22GBT307 ; DYNJ45882A , Lot Number 19GBY671 ; DYNJ45882A , Lot Number 19HBJ848 ; DYNJ45882A , Lot Number 19HBZ560 ; DYNJ45882A , Lot Number 22KBA300 ; DYNJ45882A , Lot Number 19IBZ258 ; DYNJ45882A , Lot Number 23ABE331 ; DYNJ45882A , Lot Number 20ABD585 ; DYNJ45882A , Lot Number 23DBJ543 ; DYNJ45882A , Lot Number 20ABG271 ; DYNJ45882A , Lot Number 23FBT108 ; DYNJ45882A , Lot Number 23HBC860 ; DYNJ45882A , Lot Number 20GBJ357 ; DYNJ45882A , Lot Number 20HBL822 ; DYNJ45882A , Lot Number 20IBA668 ; DYNJ45882A , Lot Number 20IBC738 ; DYNJ45882A , Lot Number 20KBE707 ; DYNJ45882A , Lot Number 20KBO720 ; DYNJ45882A , Lot Number 20LBY802 ; DYNJ45882A , Lot Number 21CBX085 ; DYNJ65199A , Lot Number 22CBF155 ; DYNJ65199A , Lot Number 22EME843 ; DYNJ65199A , Lot Number 22EME844 ; DYNJ65199A , Lot Number 23AMH680 ; DYNJ65199A , Lot Number 23DMF610 ; DYNJ65199A , Lot Number 23GMA525 ; DYNJ65199A , Lot Number 23HMA956 ; DYNJ65199A , Lot Number 23HMI132 ; DYNJ66475B , Lot Number 22GBM321 ; DYNJ80211C , Lot Number 23GBJ521 ; DYNJ80211C , Lot Number 23GBT960 ; DYNJ80211C , Lot Number 23HBG313 ; DYNJ80211C , Lot Number 23JBQ875 ; DYNJ80211C , Lot Number 23KBM933 ; DYNJ80211C , Lot Number 23LBP433 ; DYNJ80211CH, Lot Number 23GBJ521 ; DYNJ80211CH, Lot Number 23GBT960 ; DYNJ80211CH, Lot Number 23HBG313 ; DYNJ80211CH, Lot Number 23JBQ875 ; DYNJ80211CH, Lot Number 23KBM933 ; DYNJ80211CH, Lot Number 23LBP433 ; DYNJ80252C , Lot Number 23FBM038 ; DYNJ81597, Lot Number 22IBF254 ; DYNJ81597, Lot Number 23BBO299 ; DYNJ81597, Lot Number 23EBW966 ; DYNJ81597, Lot Number 23JBR560 ; DYNJ81597, Lot Number 24ABD028

Distribution pattern

Worldwide distribution.

device · product 31 of 81

Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 6) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

Z-3011-2024
Recall number
Z-3011-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDA2516B , Lot Number 23IBE112 ; DYNDA2516B , Lot Number 23JBH284 ; DYNDA2516B , Lot Number 23KBE900 ; DYNDA2516B , Lot Number 23LBO850 ; DYNDA2516BH, Lot Number 23IBE112 ; DYNDA2516BH, Lot Number 23JBH284 ; DYNDA2516BH, Lot Number 23KBE900 ; DYNDA2516BH, Lot Number 23LBO850 ; DYNJ36932A , Lot Number 23FBK320 ; DYNJ36932A , Lot Number 23GBU834 ; DYNJ36932A , Lot Number 23HBG572 ; DYNJ36932A , Lot Number 23LBL499 ; DYNJ58502C , Lot Number 21IMD970 ; DYNJ58502C , Lot Number 21KMA999 ; DYNJ910121 , Lot Number 24CDB254 ; PICCNC0028 , Lot Number 23KBL354

Distribution pattern

Worldwide distribution.

device · product 32 of 81

Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O BEDSIDE KIT , Pack Number DYKE1634 ; 5) ENDO KIT, Pack Number DYKE1696 ; 6) PULMONARY ENDO KIT, Pack Number DYKE1713 ; 7) ENDO KIT, Pack Number DYKE1739 ; 8) ENDOSCOPY PACK-LF , Pack Number DYNJ00339K ; 9) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ0190667K ; 10) CH UMBIL CATH W/INSTR PACK-LF, Pack Number DYNJ0622040Q; 11) ENDOSCOPY-LF, Pack Number DYNJ22890M ; 12) ENDOSCOPIC PACK , Pack Number DYNJ30434I ; 13) ENDOSCOPIC SINUS PACK , Pack Number DYNJ40644A ; 14) ENDOSCOPY PACK, Pack Number DYNJ40645B; 15) ENDO SURGICAL PACK WRO-LF , Pack Number DYNJ41870B ; 16) ENT PK 1008847, Pack Number DYNJ42319C ; 17) ENDOVENOUS BASIC PACK , Pack Number DYNJ42456D ; 18) UROLOGY ENDOSCOPE PACK 319738 , Pack Number DYNJ44638C ; 19) ENDOSCOPY PACK-LF , Pack Number DYNJ53271C ; 20) ENDOSCOPY , Pack Number DYNJ62133; 21) ENDOSCOPY PACK, Pack Number DYNJ62193; 22) ENDOVENOUS CORE PACK, Pack Number DYNJ62557; 23) ENDOSCOPY PACK, Pack Number DYNJ62914; 24) ENDOSCOPIC PACK , Pack Number DYNJ63797A ; 25) ENDOVENOUS ABLATION PACK, Pack Number DYNJ64059; 26) GENERAL ENDOSCOPY PACK, Pack Number DYNJ65371; 27) GYN ENDOSCOPY PACK, Pack Number DYNJ65372; 28) CV NEONATAL PACK, Pack Number DYNJ67356; 29) PEDI ENDO LAP PACK, Pack Number DYNJ68141A ; 30) ENSEMBLE CATHETER DIALYSE-LF, Pack Number DYNJ81973; 31) ENT , Pack Number DYNJ900282I; 32) MUH ENDOCRINE , Pack Number DYNJ901706J; 33) SEPTO/ENDO, Pack Number DYNJ902831D; 34) MODULE ENDO LAP , Pack Number DYNJ903026I; 35) CVOR ENDOSTENT, Pack Number DYNJ906465 ; 36) ENDOSCOPIC SKULL BASE , Pack Number DYNJ906630 ; 37) ENDO CHOLE TRAY , Pack Number LZ7759N; 38) CATHETERIZATION TRAY, Pack Number UVT1175; 39) UMBILICAL VESSEL INSERTION TRA, Pack Number UVT730; 40) TVS4000 ENDOVENOUS PACK, Pack Number TVS4000K

Z-3012-2024
Recall number
Z-3012-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS984155G , Lot Number 21GBT672 ; CDS984155G , Lot Number 21JBH429 ; CDS984155G , Lot Number 21LBP590 ; CDS984155G , Lot Number 22CBJ567 ; CDS984155G , Lot Number 22FBB170 ; CDS984155G , Lot Number 22GBB172 ; CDS984155G , Lot Number 22GBW487 ; CDS984155G , Lot Number 22HBN079 ; CDS984155G , Lot Number 22IBR934 ; CDS984155G , Lot Number 19LBO258 ; CDS984155G , Lot Number 20BBE301 ; CDS984155G , Lot Number 20EBC706 ; CDS984155G , Lot Number 20EBS188 ; CDS984155G , Lot Number 20GBA894 ; CDS984155G , Lot Number 20IBD347 ; CDS984155G , Lot Number 20JBK812 ; CDS984155G , Lot Number 21BBO717 ; CDS984155G , Lot Number 21EBO578 ; DYKE1455B, Lot Number 20GBI602 ; DYKE1487C, Lot Number 22GMD695 ; DYKE1634 , Lot Number 19DAA540 ; DYKE1634 , Lot Number 19DAB449 ; DYKE1634 , Lot Number 19JAA076 ; DYKE1634 , Lot Number 21LBY138 ; DYKE1634 , Lot Number 22ABW321 ; DYKE1634 , Lot Number 22IBN133 ; DYKE1634 , Lot Number 23ABN492 ; DYKE1634 , Lot Number 23EBE760 ; DYKE1634 , Lot Number 20BBY787 ; DYKE1634 , Lot Number 23FBP558 ; DYKE1634 , Lot Number 20EBI139 ; DYKE1634 , Lot Number 23KBU935 ; DYKE1634 , Lot Number 20HBM035 ; DYKE1634 , Lot Number 20IBS530 ; DYKE1634 , Lot Number 20JBF837 ; DYKE1696 , Lot Number 23LMF046 ; DYKE1713 , Lot Number 22ABU757 ; DYKE1713 , Lot Number 22BBY210 ; DYKE1713 , Lot Number 22GBJ615 ; DYKE1713 , Lot Number 22KBC587 ; DYKE1713 , Lot Number 19JBJ509 ; DYKE1713 , Lot Number 23BBL166 ; DYKE1713 , Lot Number 23BBU192 ; DYKE1713 , Lot Number 23EBA547 ; DYKE1713 , Lot Number 20BBA308 ; DYKE1713 , Lot Number 23FBT851 ; DYKE1713 , Lot Number 20CBW284 ; DYKE1713 , Lot Number 20DBU069 ; DYKE1713 , Lot Number 23JBY319 ; DYKE1713 , Lot Number 23KBI749 ; DYKE1713 , Lot Number 20IBD604 ; DYKE1713 , Lot Number 20IBD920 ; DYKE1713 , Lot Number 21BBR876 ; DYKE1713 , Lot Number 21CBZ238 ; DYKE1713 , Lot Number 21EBI062 ; DYKE1713 , Lot Number 21EBI179 ; DYKE1739 , Lot Number 21FBI996 ; DYKE1739 , Lot Number 20ABX716 ; DYKE1739 , Lot Number 20DBC649 ; DYKE1739 , Lot Number 20GBJ601 ; DYKE1739 , Lot Number 20HBB784 ; DYKE1739 , Lot Number 20HBK727 ; DYKE1739 , Lot Number 20HBS038 ; DYKE1739 , Lot Number 20IBC158 ; DYKE1739 , Lot Number 20JBU785 ; DYKE1739 , Lot Number 20KBC347 ; DYKE1739 , Lot Number 21CBK025 ; DYKE1739 , Lot Number 21GMB307 ; DYKE1739 , Lot Number 21HMF607 ; DYKE1739 , Lot Number 21JMF960 ; DYKE1739 , Lot Number 21KMG583 ; DYKE1739 , Lot Number 21LMF454 ; DYKE1739 , Lot Number 22DMB064 ; DYKE1739 , Lot Number 22EMH721 ; DYKE1739 , Lot Number 22IMC388 ; DYKE1739 , Lot Number 23BMC773 ; DYKE1739 , Lot Number 23GMA887 ; DYKE1739 , Lot Number 23HMB551 ; DYKE1739 , Lot Number 23HMH146 ; DYKE1739 , Lot Number 23IMD762 ; DYKE1739 , Lot Number 23JMB830 ; DYKE1739 , Lot Number 23LMB870 ; DYNJ00339K , Lot Number 20FMB927 ; DYNJ00339K , Lot Number 20IMD268 ; DYNJ00339K , Lot Number 20JMA687 ; DYNJ00339K , Lot Number 20KME960 ; DYNJ00339K , Lot Number 21FMF410 ; DYNJ00339K , Lot Number 21GMD690 ; DYNJ00339K , Lot Number 21IMC817 ; DYNJ00339K , Lot Number 21JMB868 ; DYNJ00339K , Lot Number 21JMI001 ; 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DYNJ0190667K , Lot Number 21GME698 ; DYNJ0190667K , Lot Number 21IMC659 ; DYNJ0190667K , Lot Number 21LMG066 ; DYNJ0190667K , Lot Number 22AMB738 ; DYNJ0190667K , Lot Number 22BMG712 ; DYNJ0190667K , Lot Number 22CME680 ; DYNJ0190667K , Lot Number 22DMB770 ; DYNJ0190667K , Lot Number 22FMA583 ; DYNJ0190667K , Lot Number 22HMA944 ; DYNJ0190667K , Lot Number 22IMD456 ; DYNJ0190667K , Lot Number 22LMC230 ; DYNJ0190667K , Lot Number 23AMH577 ; DYNJ0190667K , Lot Number 23AMI382 ; DYNJ0190667K , Lot Number 23CMD624 ; DYNJ0190667K , Lot Number 23DMC091 ; DYNJ0190667K , Lot Number 23EME584 ; DYNJ0190667K , Lot Number 23FMD211 ; DYNJ0190667K , Lot Number 23GMF632 ; DYNJ0190667K , Lot Number 23HME743 ; DYNJ0190667K , Lot Number 23IMG608 ; DYNJ0190667K , Lot Number 23JMH633 ; DYNJ0190667K , Lot Number 23LMF564 ; DYNJ0622040Q, Lot Number 24BLA601; DYNJ0622040Q, Lot Number 24ALA070; DYNJ0622040Q, Lot Number 23HLA750; DYNJ0622040Q, Lot Number 23ALA491; DYNJ0622040Q, Lot Number 22JLA277; DYNJ0622040Q, Lot Number 22ILB030; DYNJ0622040Q, Lot Number 22ILA821; DYNJ0622040Q, Lot Number 22ILA226; DYNJ0622040Q, Lot Number 22HLA876; DYNJ22890M , Lot Number 21JBX107 ; DYNJ22890M , Lot Number 21KBO873 ; DYNJ22890M , Lot Number 21KBO877 ; DYNJ22890M , Lot Number 22ABJ346 ; DYNJ22890M , Lot Number 19HBM059 ; DYNJ22890M , Lot Number 22JBM081 ; DYNJ22890M , Lot Number 19IBT334 ; DYNJ22890M , Lot Number 19KBS750 ; DYNJ22890M , Lot Number 19KBW317 ; DYNJ22890M , Lot Number 23DBM600 ; DYNJ22890M , Lot Number 20BBG920 ; DYNJ22890M , Lot Number 20CBQ486 ; DYNJ22890M , Lot Number 21BBB024 ; DYNJ22890M , Lot Number 21BBE213 ; DYNJ30434I , Lot Number 19FBC091 ; DYNJ30434I , Lot Number 19FBO586 ; DYNJ30434I , Lot Number 19HBT794 ; DYNJ30434I , Lot Number 19JBL207 ; DYNJ30434I , Lot Number 19JMA742 ; DYNJ30434I , Lot Number 20AMA906 ; DYNJ30434I , Lot Number 20BMB432 ; DYNJ30434I , Lot Number 20BMB950 ; DYNJ30434I , Lot Number 20CMB292 ; DYNJ30434I , Lot Number 20HMA247 ; DYNJ30434I , Lot Number 20HMD625 ; DYNJ30434I , Lot Number 20IMC739 ; DYNJ30434I , Lot Number 21AME134 ; DYNJ30434I , Lot Number 21BME286 ; DYNJ30434I , Lot Number 21CME244 ; DYNJ30434I , Lot Number 21EMC851 ; DYNJ30434I , Lot Number 21FMD635 ; DYNJ30434I , Lot Number 21HME258 ; DYNJ30434I , Lot Number 21IMA388 ; DYNJ30434I , Lot Number 21JMD320 ; DYNJ30434I , Lot Number 21KMF781 ; DYNJ30434I , Lot Number 22AMB792 ; DYNJ30434I , Lot Number 22FMH427 ; DYNJ40644A , Lot Number 20CMB952 ; DYNJ40644A , Lot Number 20HMB559 ; DYNJ40644A , Lot Number 20KMA468 ; DYNJ40644A , Lot Number 20KMB182 ; DYNJ40644A , Lot Number 20KMC866 ; DYNJ40644A , Lot Number 21AME524 ; DYNJ40644A , Lot Number 21DMA759 ; DYNJ40644A , Lot Number 21EME248 ; DYNJ40644A , Lot Number 21GMB592 ; DYNJ40644A , Lot Number 21HMC615 ; DYNJ40644A , Lot Number 21IMF418 ; DYNJ40644A , Lot Number 21JMA505 ; DYNJ40644A , Lot Number 21KMG859 ; DYNJ40644A , Lot Number 21LMF984 ; DYNJ40645B, Lot Number 22AMD386; DYNJ40645B, Lot Number 21LMC822; DYNJ40645B, Lot Number 21JMF409; DYNJ40645B, Lot Number 21IMC184; DYNJ40645B, Lot Number 21GMB555; DYNJ41870B , Lot Number 21FBS263 ; DYNJ41870B , Lot Number 21GBJ652 ; DYNJ41870B , Lot Number 21IBC888 ; DYNJ41870B , Lot Number 22BBJ487 ; DYNJ41870B , Lot Number 22BBJ492 ; DYNJ41870B , Lot Number 22BBR105 ; DYNJ41870B , Lot Number 19EBN573 ; DYNJ41870B , Lot Number 19FBB623 ; DYNJ41870B , Lot Number 19FBC317 ; DYNJ41870B , Lot Number 22GBU057 ; DYNJ41870B , Lot Number 22JBQ322 ; DYNJ41870B , Lot Number 23ABG049 ; DYNJ41870B , Lot Number 19VBD185 ; DYNJ41870B , Lot Number 23BBU327 ; DYNJ41870B , Lot Number 23BBU418 ; DYNJ41870B , Lot Number 19WBA041 ; DYNJ41870B , Lot Number 20BBF643 ; DYNJ41870B , Lot Number 20CBX489 ; DYNJ41870B , Lot Number 20DBQ198 ; DYNJ41870B , Lot Number 20EBE927 ; DYNJ41870B , Lot Number 20EBG738 ; DYNJ41870B , Lot Number 20FBF015 ; DYNJ42319C , Lot Number 21KBD492 ; DYNJ42319C , Lot Number 21LBG900 ; DYNJ42319C , Lot Number 22ABA711 ; DYNJ42319C , Lot Number 22BBT747 ; DYNJ42319C , Lot Number 22OBB494 ; DYNJ42319C , Lot Number 20ABA663 ; 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DYNJ53271C , Lot Number 19FBR626 ; DYNJ53271C , Lot Number 22GBV025 ; DYNJ53271C , Lot Number 22HBD540 ; DYNJ53271C , Lot Number 19HBR716 ; DYNJ53271C , Lot Number 22JBJ775 ; DYNJ53271C , Lot Number 22JBX045 ; DYNJ53271C , Lot Number 22LBE488 ; DYNJ53271C , Lot Number 19JBE895 ; DYNJ53271C , Lot Number 23BBA553 ; DYNJ53271C , Lot Number 19LBD484 ; DYNJ53271C , Lot Number 23CBI223 ; DYNJ53271C , Lot Number 23DBK795 ; DYNJ53271C , Lot Number 23EBS925 ; DYNJ53271C , Lot Number 20BBI657 ; DYNJ53271C , Lot Number 23GBH019 ; DYNJ53271C , Lot Number 20CBR785 ; DYNJ53271C , Lot Number 23HBU868 ; DYNJ53271C , Lot Number 20FBF734 ; DYNJ53271C , Lot Number 23JBD689 ; DYNJ53271C , Lot Number 23KBG525 ; DYNJ53271C , Lot Number 20HBE090 ; DYNJ53271C , Lot Number 23LBU090 ; DYNJ53271C , Lot Number 20JBL759 ; DYNJ53271C , Lot Number 20LBI588 ; DYNJ53271C , Lot Number 21CBE721 ; DYNJ53271C , Lot Number 21EBA973 ; DYNJ62133, Lot Number 21KBD805 ; DYNJ62133, Lot Number 21KBP864 ; DYNJ62133, Lot Number 21LBQ348 ; DYNJ62133, Lot Number 22BBO070 ; DYNJ62133, Lot Number 22DBM856 ; DYNJ62133, Lot Number 22DBN285 ; DYNJ62133, Lot Number 22FBY593 ; DYNJ62133, Lot Number 22IBQ159 ; DYNJ62133, Lot Number 22JBG314 ; DYNJ62133, Lot Number 22KBR310 ; DYNJ62133, Lot Number 22LBK846 ; DYNJ62133, Lot Number 23BBF608 ; DYNJ62133, Lot Number 23BBQ891 ; DYNJ62133, Lot Number 23CBW335 ; DYNJ62133, Lot Number 23EBD781 ; DYNJ62133, Lot Number 23FBC879 ; DYNJ62133, Lot Number 23HBT273 ; DYNJ62133, Lot Number 23KBD907 ; DYNJ62133, Lot Number 23LBA384 ; DYNJ62133, Lot Number 24ABU004 ; DYNJ62193, Lot Number 19CDC012 ; DYNJ62193, Lot Number 19EDC720 ; DYNJ62193, Lot Number 19IDA133 ; DYNJ62193, Lot Number 19KDB481 ; DYNJ62193, Lot Number 19LDC402 ; DYNJ62193, Lot Number 20BDB103 ; DYNJ62193, Lot Number 20CDB344 ; DYNJ62193, Lot Number 20DDA727 ; DYNJ62193, Lot Number 20EDA231 ; DYNJ62193, Lot Number 20FDA990 ; DYNJ62193, Lot Number 20IDA148 ; DYNJ62193, Lot Number 21BDB558 ; DYNJ62193, Lot Number 21CDB970 ; DYNJ62193, Lot Number 21DDB909 ; 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DYNJ65371, Lot Number 22OBH515 ; DYNJ65371, Lot Number 22FBN339 ; DYNJ65371, Lot Number 22GBH478 ; DYNJ65371, Lot Number 20BBP676 ; DYNJ65371, Lot Number 20GBS807 ; DYNJ65371, Lot Number 20GBT451 ; DYNJ65371, Lot Number 20JBB071 ; DYNJ65371, Lot Number 20JBG719 ; DYNJ65371, Lot Number 20LBY530 ; DYNJ65371, Lot Number 21BBI536 ; DYNJ65371, Lot Number 21EBB482 ; DYNJ65371, Lot Number 22HMG325 ; DYNJ65371, Lot Number 22HMG333 ; DYNJ65371, Lot Number 22JME136 ; DYNJ65371, Lot Number 22JME143 ; DYNJ65371, Lot Number 23AMD834 ; DYNJ65371, Lot Number 23CMF481 ; DYNJ65371, Lot Number 23DMI706 ; DYNJ65372, Lot Number 22OBE240 ; DYNJ65372, Lot Number 20BBR012 ; DYNJ65372, Lot Number 20HBR404 ; DYNJ65372, Lot Number 20IBJ748 ; DYNJ65372, Lot Number 20JBR868 ; DYNJ67356, Lot Number 21FBL509 ; DYNJ67356, Lot Number 21LBC407 ; DYNJ67356, Lot Number 21LBQ690 ; DYNJ67356, Lot Number 22EMB961 ; DYNJ67356, Lot Number 22FMD091 ; DYNJ67356, Lot Number 22HMB876 ; DYNJ67356, Lot Number 22JMD170 ; DYNJ67356, Lot Number 22LMA801 ; 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UVT1175, Lot Number 22ABX753 ; UVT1175, Lot Number 22CBJ600 ; UVT1175, Lot Number 23GMC946 ; UVT1175, Lot Number 23HMA547 ; UVT1175, Lot Number 23HMC187 ; UVT1175, Lot Number 23IMC220 ; UVT1175, Lot Number 23JMF023 ; UVT730, Lot Number 23DBO225; UVT730, Lot Number 23BBJ969; UVT730, Lot Number 23BBD067; UVT730, Lot Number 22HBR771; UVT730, Lot Number 22FBN134; UVT730, Lot Number 22FBI749; UVT730, Lot Number 22BBZ635; UVT730, Lot Number 22ABB949; UVT730, Lot Number 21KBC744; UVT730, Lot Number 21IBT312; UVT730, Lot Number 21GBK102; UVT730, Lot Number 23DBO225; UVT730, Lot Number 23BBJ969; UVT730, Lot Number 23BBD067; UVT730, Lot Number 22HBR771; UVT730, Lot Number 22FBN134; UVT730, Lot Number 22FBI749; UVT730, Lot Number 22BBZ635; UVT730, Lot Number 22ABB949; UVT730, Lot Number 21KBC744; UVT730, Lot Number 21IBT312; UVT730, Lot Number 21GBK102; TVS4000K, Lot Number 22FDB699

Distribution pattern

Worldwide distribution.

device · product 33 of 81

Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799

Z-3013-2024
Recall number
Z-3013-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ42742D , Lot Number 19ABF928 ; DYNJ42742D , Lot Number 19BBC938 ; DYNJ42742D , Lot Number 19PBB060 ; DYNJ42742D , Lot Number 19GBO530 ; DYNJ42742D , Lot Number 19HBH965 ; DYNJ42742D , Lot Number 19HBJ692 ; DYNJ42799, Lot Number 21GBH529 ; DYNJ42799, Lot Number 19CBO493 ; DYNJ42799, Lot Number 19EBF614 ; DYNJ42799, Lot Number 19FBD772 ; DYNJ42799, Lot Number 19GBE887 ; DYNJ42799, Lot Number 19HBI404 ; DYNJ42799, Lot Number 19IBT472 ; DYNJ42799, Lot Number 20ABD578 ; DYNJ42799, Lot Number 20CBF124 ; DYNJ42799, Lot Number 20DBC424 ; DYNJ42799, Lot Number 20EBT962 ; DYNJ42799, Lot Number 20JBF487 ; DYNJ42799, Lot Number 20JBZ120 ; DYNJ42799, Lot Number 21ABV059 ; DYNJ42799, Lot Number 21BBM615 ; DYNJ42799, Lot Number 21EBP168 ; DYNJ42799, Lot Number 21EBP171

Distribution pattern

Worldwide distribution.

device · product 34 of 81

Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023

Z-3014-2024
Recall number
Z-3014-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJRA1023 , Lot Number 21IBW483 ; DYNJRA1023 , Lot Number 22ABH162 ; DYNJRA1023 , Lot Number 19BBA260 ; DYNJRA1023 , Lot Number 19FBP403 ; DYNJRA1023 , Lot Number 19IBY026 ; DYNJRA1023 , Lot Number 19KBX011 ; DYNJRA1023 , Lot Number 20EBK333 ; DYNJRA1023 , Lot Number 20GBU419 ; DYNJRA1023 , Lot Number 20HBS695 ; DYNJRA1023 , Lot Number 20KBF923

Distribution pattern

Worldwide distribution.

device · product 35 of 81

Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Number DYNJ66416; 6) DRAINAGE TRAY , Pack Number DYNJ68767; 7) INCISION AND DRAINAGE TRAY, Pack Number P737057

Z-3015-2024
Recall number
Z-3015-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

146255, Lot Number 23KBP730; 146255, Lot Number 23JBV770; 146255, Lot Number 23BBJ516; 146255, Lot Number 23ABS205; 146255, Lot Number 22LBQ260; 146255, Lot Number 22LBF150; CVI5080, Lot Number 24ABR654 ; CVI5080, Lot Number 24ABS414 ; DYNDA1063, Lot Number 21JBR507 ; DYNJ44599I , Lot Number 21FBO112 ; DYNJ44599I , Lot Number 21GBQ754 ; DYNJ44599I , Lot Number 21HBU200 ; DYNJ44599I , Lot Number 21KBM267 ; DYNJ44599I , Lot Number 21LBQ208 ; DYNJ44599I , Lot Number 22NBE952 ; DYNJ44599I , Lot Number 22EBA808 ; DYNJ44599I , Lot Number 22EBV387 ; DYNJ44599I , Lot Number 22GBL830 ; DYNJ44599I , Lot Number 22HBM625 ; DYNJ44599I , Lot Number 22IBN180 ; DYNJ44599I , Lot Number 22JBH998 ; DYNJ44599I , Lot Number 22JBX287 ; DYNJ44599I , Lot Number 23ABJ748 ; DYNJ44599I , Lot Number 23BBO863 ; DYNJ44599I , Lot Number 23CBU289 ; DYNJ44599I , Lot Number 23DBO841 ; DYNJ44599I , Lot Number 23EBP969 ; DYNJ44599I , Lot Number 23GBG623 ; DYNJ44599I , Lot Number 23HBR164 ; DYNJ44599I , Lot Number 20EBC852 ; DYNJ44599I , Lot Number 23IBU633 ; DYNJ44599I , Lot Number 20FBO439 ; DYNJ44599I , Lot Number 20GBA511 ; DYNJ44599I , Lot Number 23KBI875 ; DYNJ44599I , Lot Number 24ABA732 ; DYNJ44599I , Lot Number 20JBA956 ; DYNJ44599I , Lot Number 20JBZ002 ; DYNJ44599I , Lot Number 20KBD800 ; DYNJ44599I , Lot Number 20LBI387 ; DYNJ44599I , Lot Number 21CBN891 ; DYNJ44599I , Lot Number 21CBX162 ; DYNJ66416, Lot Number 20GKA807 ; DYNJ68767, Lot Number 21HLA622 ; DYNJ68767, Lot Number 21KLA137 ; DYNJ68767, Lot Number 21LLA666 ; DYNJ68767, Lot Number 22BLA542 ; DYNJ68767, Lot Number 22DLB131 ; DYNJ68767, Lot Number 22HLA449 ; DYNJ68767, Lot Number 22ILA208 ; DYNJ68767, Lot Number 22KLA881 ; DYNJ68767, Lot Number 23ALA469 ; DYNJ68767, Lot Number 23BLA292 ; DYNJ68767, Lot Number 23CLA817 ; DYNJ68767, Lot Number 23ELA407 ; DYNJ68767, Lot Number 23ELA587 ; DYNJ68767, Lot Number 23KLA248 ; DYNJ68767, Lot Number 23LLA473 ; P737057, Lot Number 21VBC482

Distribution pattern

Worldwide distribution.

device · product 36 of 81

Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6) BREAST/MINOR, Pack Number CDS980228W ; 7) PLASTIC CDS , Pack Number CDS980232U ; 8) PLASTIC CDS , Pack Number CDS980232V ; 9) PLASTIC CDS , Pack Number CDS980232W ; 10) PLASTIC CDS , Pack Number CDS980232X ; 11) LTP CDS-LF, Pack Number CDS980375L ; 12) PLASTIC CDS , Pack Number CDS980457R ; 13) PLASTIC CDS , Pack Number CDS980457S ; 14) PLASTIC CDS , Pack Number CDS980457T ; 15) BREAST AUG, Pack Number CDS980567R ; 16) BREAST AUG, Pack Number CDS980567S ; 17) LARGE PROCEDURE-LF, Pack Number CDS981257J ; 18) LARGE PROCEDURE-LF, Pack Number CDS981257K ; 19) BREAST CDS, Pack Number CDS981691N ; 20) MAJOR PLASTICS CDS, Pack Number CDS981958I ; 21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ; 22) MINOR PLASTIC , Pack Number CDS982018K ; 23) MAJOR BREAST, Pack Number CDS982038S ; 24) VASAL RECONSTRUCTION, Pack Number CDS982042O ; 25) MINOR BREAST, Pack Number CDS982053M ; 26) MINOR BREAST, Pack Number CDS982053N ; 27) MINOR BREAST, Pack Number CDS982053O ; 28) MINOR BREAST, Pack Number CDS982053P ; 29) BREAST AUGMENTATION , Pack Number CDS982254K ; 30) BREAST AUGMENTATION , Pack Number CDS982254L ; 31) BREAST AUGMENTATION , Pack Number CDS982254M ; 32) BREAST REDUCTION CDS, Pack Number CDS982255G ; 33) BREAST REDUCTION CDS, Pack Number CDS982255I ; 34) BREAST REDUCTION, Pack Number CDS982255J ; 35) TYMPANOPLASTY , Pack Number CDS982720M ; 36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ; 37) REDUCTION CDS , Pack Number CDS982776J ; 38) REDUCTION CDS , Pack Number CDS982776K ; 39) REDUCTION CDS , Pack Number CDS982776L ; 40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ; 41) MAG PLASTIC CDS , Pack Number CDS982909I ; 42) MAG PLASTIC CDS , Pack Number CDS982909J ; 43) MAG PLASTIC CDS , Pack Number CDS982909K ; 44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ; 45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ; 46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ; 47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ; 48) GENERAL BREAST, Pack Number CDS983058G ; 49) GENERAL BREAST, Pack Number CDS983058I ; 50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ; 51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ; 52) BREAST CDS, Pack Number CDS983148A ; 53) BREAST CDS, Pack Number CDS983148B ; 54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ; 55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ; 56) MAJOR CDS , Pack Number CDS983292D ; 57) PECTUS REPAIR , Pack Number CDS983353R ; 58) PECTUS REPAIR , Pack Number CDS983353S ; 59) PECTUS REPAIR , Pack Number CDS983353T ; 60) PECTUS REPAIR , Pack Number CDS983353U ; 61) PECTUS REPAIR , Pack Number CDS983353V ; 62) PECTUS REPAIR , Pack Number CDS983353X ; 63) MAMMOPLASTY-LF, Pack Number CDS983478J ; 64) MAMMOPLASTY-LF, Pack Number CDS983478K ; 65) MAMMOPLASTY-LF, Pack Number CDS983478L ; 66) PLASTICS FREE FLAP, Pack Number CDS983493L; 67) PLASTICS FREE FLAP, Pack Number CDS983493M; 68) PLASTIC TORSO-LF, Pack Number CDS983496I ; 69) PLASTIC TORSO-LF, Pack Number CDS983496J ; 70) PLASTIC TORSO-LF, Pack Number CDS983496K ; 71) PLASTIC TORSO-LF, Pack Number CDS983496L ; 72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ; 73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ; 74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ; 75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ; 76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ; 77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ; 78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ; 79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ; 80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ; 81) NE BREAST RECON CDS , Pack Number CDS983660D ; 82) NE BREAST RECON

Z-3016-2024
Recall number
Z-3016-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS920066K , Lot Number 19ABM835 ; CDS920066K , Lot Number 19CBD966 ; CDS920066K , Lot Number 19DBS028 ; CDS920066L , Lot Number 19FBR839 ; CDS920066L , Lot Number 20DBM938 ; CDS920066L , Lot Number 20GBG553 ; CDS920066L , Lot Number 20IBF930 ; CDS920066L , Lot Number 20IBL798 ; CDS980088K , Lot Number 19ABF841 ; CDS980088K , Lot Number 19BBR779 ; CDS980088K , Lot Number 19CBI036 ; CDS980088K , Lot Number 19EBY389 ; CDS980088K , Lot Number 19HBO214 ; CDS980088K , Lot Number 19HBU649 ; CDS980088K , Lot Number 19IBX782 ; CDS980200AA, Lot Number 21HBO940 ; CDS980200AA, Lot Number 21KBH187 ; CDS980200AA, Lot Number 22ABI736 ; CDS980200AA, Lot Number 22EBS477 ; CDS980200AA, Lot Number 22FBE877 ; CDS980200AA, Lot Number 22FBG077 ; CDS980200AA, Lot Number 22GBA222 ; CDS980200AA, Lot Number 22HBL578 ; CDS980200AA, Lot Number 22HBN078 ; CDS980200AA, Lot Number 22IBD419 ; CDS980200AA, Lot Number 22JBQ932 ; CDS980200AA, Lot Number 22KBJ570 ; CDS980200AA, Lot Number 22KBM262 ; CDS980200AA, Lot Number 23ABN721 ; CDS980200AA, Lot Number 23CBD776 ; CDS980200AA, Lot Number 23EBD623 ; CDS980200AA, Lot Number 23EBK657 ; CDS980200AA, Lot Number 23HBK655 ; CDS980200AA, Lot Number 23IBU758 ; CDS980200AA, Lot Number 23JBJ092 ; CDS980200AA, Lot Number 23KBA249 ; CDS980200AA, Lot Number 24ABV345 ; CDS980200AA, Lot Number 21CBF899 ; CDS980200AA, Lot Number 21EBO710 ; CDS980200Y , Lot Number 19ABR558 ; CDS980200Y , Lot Number 19DBG664 ; CDS980200Y , Lot Number 19FBZ748 ; CDS980200Y , Lot Number 19HBB367 ; CDS980200Y , Lot Number 19TBB908 ; CDS980200Y , Lot Number 19JBC014 ; CDS980200Y , Lot Number 19KBN743 ; CDS980200Y , Lot Number 20BBE167 ; CDS980200Y , Lot Number 20DBH152 ; CDS980200Y , Lot Number 20FBR880 ; CDS980200Y , Lot Number 20HBE774 ; CDS980200Y , Lot Number 20IBG766 ; CDS980200Y , Lot Number 20JBR282 ; CDS980200Y , Lot Number 20LBQ487 ; CDS980200Y , Lot Number 21ABC248 ; CDS980228W , Lot Number 19ABW907 ; CDS980228W , Lot Number 19BBL561 ; CDS980228W , Lot Number 19CBM174 ; CDS980228W , Lot Number 19EBN810 ; CDS980228W , Lot Number 19FBN128 ; CDS980228W , Lot Number 19HBH107 ; CDS980228W , Lot Number 19HBX070 ; CDS980228W , Lot Number 19JBA329 ; CDS980228W , Lot Number 19KBH852 ; CDS980228W , Lot Number 19LBR795 ; CDS980228W , Lot Number 20BBQ462 ; CDS980228W , Lot Number 20BBZ179 ; CDS980228W , Lot Number 20EBI895 ; CDS980228W , Lot Number 20FBK517 ; CDS980228W , Lot Number 20GBR042 ; CDS980228W , Lot Number 20IBI018 ; CDS980228W , Lot Number 20JBR049 ; CDS980228W , Lot Number 20KBT175 ; CDS980228W , Lot Number 21ABC714 ; CDS980228W , Lot Number 21BBG051 ; CDS980228W , Lot Number 21CBU644 ; CDS980228W , Lot Number 21EBH357 ; CDS980232U , Lot Number 19BBH968 ; CDS980232U , Lot Number 19CBK976 ; CDS980232U , Lot Number 19EBU029 ; CDS980232U , Lot Number 19FBS139 ; CDS980232U , Lot Number 19GBW172 ; CDS980232U , Lot Number 19HBM330 ; CDS980232U , Lot Number 19VBF307 ; CDS980232U , Lot Number 19LBK396 ; CDS980232V , Lot Number 19KBR773 ; CDS980232V , Lot Number 20ABF339 ; CDS980232V , Lot Number 20BBB986 ; CDS980232V , Lot Number 20BBU668 ; CDS980232V , Lot Number 20CBR984 ; CDS980232V , Lot Number 20CBW496 ; CDS980232V , Lot Number 20DBL307 ; CDS980232V , Lot Number 20EBO737 ; CDS980232V , Lot Number 20FBF081 ; CDS980232V , Lot Number 20GBB769 ; CDS980232V , Lot Number 20HBE599 ; CDS980232V , Lot Number 20IBF392 ; CDS980232V , Lot Number 20IBR161 ; CDS980232V , Lot Number 20KBB632 ; CDS980232V , Lot Number 20LBS158 ; CDS980232V , Lot Number 21BBD337 ; CDS980232V , Lot Number 21BBF806 ; CDS980232V , Lot Number 21CBT360 ; CDS980232V , Lot Number 21DBC544 ; CDS980232V , Lot Number 21EBI364 ; CDS980232W , Lot Number 21IBL710 ; CDS980232W , Lot Number 21IBP897 ; CDS980232W , Lot Number 21IBP933 ; CDS980232W , Lot Number 22CBT696 ; CDS980232W , Lot Number 22DBM998 ; CDS980232W , Lot Number 22EBA374 ; CDS980232W , Lot Number 22FBM675 ; CDS980232W , Lot Number 22FBQ776 ; CDS980232W , Lot Number 22GBJ142 ; CDS980232W , Lot Number 22IBC631 ; CDS980232W , Lot Number 22JBH353 ; CDS980232W , Lot Number 22KBI842 ; CDS980232W , Lot Number 23ABC334 ; CDS980232W , Lot Number 23ABR031 ; CDS980232W , Lot Number 23CBQ219 ; CDS980232W , Lot Number 23EBE138 ; CDS980232W , Lot Number 23EBR956 ; CDS980232W , Lot Number 23FBL917 ; CDS980232W , Lot Number 23HBH389 ; CDS980232W , Lot Number 23HBS954 ; CDS980232X , Lot Number 24ABB890 ; CDS980232X , Lot Number 24ABC730 ; CDS980232X , Lot Number 24ABP304 ; CDS980375L , Lot Number 21HBG608 ; CDS980375L , Lot Number 21IBT137 ; CDS980375L , Lot Number 22CBX667 ; CDS980375L , Lot Number 22DBS948 ; CDS980375L , Lot Number 22FBX069 ; CDS980375L , Lot Number 22IBF741 ; CDS980375L , Lot Number 22KBC504 ; CDS980375L , Lot Number 22LBI985 ; CDS980375L , Lot Number 23DBF906 ; CDS980375L , Lot Number 23GBD593 ; CDS980375L , Lot Number 23GBD781 ; CDS980375L , Lot Number 23KBN711 ; CDS980375L , Lot Number 23KBW165 ; CDS980457R , Lot Number 19ABN815 ; CDS980457R , Lot Number 19EBU647 ; CDS980457R , Lot Number 19HBE668 ; CDS980457R , Lot Number 19IBF973 ; CDS980457R , Lot Number 19LBI230 ; CDS980457R , Lot Number 20BBA372 ; CDS980457R , Lot Number 20DBQ371 ; CDS980457R , Lot Number 20GBJ958 ; CDS980457S , Lot Number 21LBD714 ; CDS980457S , Lot Number 22BBZ405 ; CDS980457S , Lot Number 22EMG704 ; CDS980457S , Lot Number 22HMH882 ; CDS980457S , Lot Number 23AME148 ; CDS980457S , Lot Number 23BMB462 ; CDS980457S , Lot Number 23DMH737 ; CDS980457T , Lot Number 23GMA948 ; CDS980457T , Lot Number 23GMF038 ; CDS980567R , Lot Number 19CBB293 ; CDS980567R , Lot Number 19DBZ728 ; CDS980567R , Lot Number 19FBG689 ; CDS980567S , Lot Number 19FBG716 ; CDS980567S , Lot Number 19HBK399 ; CDS980567S , Lot Number 19IBT497 ; CDS980567S , Lot Number 20BBC189 ; CDS981257J , Lot Number 21FBN638 ; CDS981257J , Lot Number 21FBR091 ; CDS981257J , Lot Number 19CBD409 ; CDS981257J , Lot Number 19DBL599 ; CDS981257J , Lot Number 19EBD716 ; CDS981257J , Lot Number 19FBQ266 ; CDS981257J , Lot Number 19GBL111 ; CDS981257J , Lot Number 19HBA947 ; CDS981257J , Lot Number 19IBQ134 ; CDS981257J , Lot Number 19KBP671 ; CDS981257J , Lot Number 19KBQ866 ; CDS981257J , Lot Number 20CBD269 ; CDS981257J , Lot Number 20EBA007 ; CDS981257J , Lot Number 20EBC274 ; CDS981257J , Lot Number 20GBH203 ; CDS981257J , Lot Number 20HBI869 ; CDS981257J , Lot Number 20HBV936 ; CDS981257J , Lot Number 20IBF406 ; CDS981257J , Lot Number 20IBS593 ; CDS981257J , Lot Number 20JBN637 ; CDS981257J , Lot Number 21CBB696 ; CDS981257J , Lot Number 21DBF086 ; CDS981257J , Lot Number 21EBC573 ; CDS981257J , Lot Number 21EBG508 ; CDS981257J , Lot Number 21GMC225 ; CDS981257K , Lot Number 21KME233 ; CDS981257K , Lot Number 21KMH490 ; CDS981257K , Lot Number 21LMD144 ; CDS981257K , Lot Number 22AMD021 ; CDS981257K , Lot Number 22AMD022 ; CDS981257K , Lot Number 22AMG535 ; CDS981257K , Lot Number 22DME520 ; CDS981257K , Lot Number 22GMA213 ; CDS981257K , Lot Number 22GMF576 ; CDS981257K , Lot Number 22JMA037 ; CDS981257K , Lot Number 22KMD512 ; CDS981257K , Lot Number 22LMD006 ; CDS981257K , Lot Number 23AMB195 ; CDS981257K , Lot Number 23AMF452 ; CDS981257K , Lot Number 23AMG701 ; CDS981257K , Lot Number 23DMI539 ; CDS981257K , Lot Number 23EMD596 ; CDS981257K , Lot Number 23EMG510 ; CDS981257K , Lot Number 23EMI980 ; CDS981257K , Lot Number 23GMC869 ; CDS981257K , Lot Number 23GMI568 ; CDS981257K , Lot Number 23IMC179 ; CDS981257K , Lot Number 23JMB398 ; CDS981257K , Lot Number 23KMC027 ; CDS981257K , Lot Number 23KMH664 ; CDS981257K , Lot Number 23LMH862 ; CDS981257K , Lot Number 24AMH806 ; CDS981691N , Lot Number 21EME333 ; CDS981691N , Lot Number 21GME796 ; CDS981691N , Lot Number 21JMB026 ; CDS981691N , Lot Number 21JMI360 ; CDS981691N , Lot Number 21LMG394 ; CDS981691N , Lot Number 22AME297 ; CDS981691N , Lot Number 22CMC509 ; CDS981691N , Lot Number 22FMF879 ; CDS981691N , Lot Number 22IMA979 ; CDS981691N , Lot Number 22IMC189 ; CDS981691N , Lot Number 22IMD080 ; CDS981691N , Lot Number 22JMA039 ; CDS981691N , Lot Number 22JME639 ; CDS981691N , Lot Number 23CMG688 ; CDS981691N , Lot Number 23DME083 ; CDS981691N , Lot Number 19AKB352 ; CDS981691N , Lot Number 19BKA421 ; CDS981691N , Lot Number 19BKD063 ; CDS981691N , Lot Number 19CKC346 ; CDS981691N , Lot Number 19DKB150 ; CDS981691N , Lot Number 19EKD156 ; CDS981691N , Lot Number 19FKB545 ; CDS981691N , Lot Number 19GKB205 ; CDS981691N , Lot Number 19HKA748 ; CDS981691N , Lot Number 19HKC704 ; CDS981691N , Lot Number 19JKA921 ; CDS981691N , Lot Number 19LKB015 ; CDS981691N , Lot Number 20CKA733 ; CDS981691N , Lot Number 20EKB934 ; CDS981691N , Lot Number 20IKB130 ; CDS981691N , Lot Number 20KKA685 ; CDS981691N , Lot Number 21AKA403 ; CDS981691N , Lot Number 21BKA460 ; CDS981691N , Lot Number 21DKA185 ; CDS981958I , Lot Number 19CBM315 ; CDS981958I , Lot Number 19EBZ741 ; CDS981958I , Lot Number 19HBH832 ; CDS981958I , Lot Number 19IBE324 ; CDS981958I , Lot Number 19VBE088 ; CDS981958I , Lot Number 20FBC068 ; CDS981958I , Lot Number 20FBS317 ; CDS981958I , Lot Number 20GBP254 ; CDS981958I , Lot Number 20HBG317 ; CDS981958I , Lot Number 20IBC427 ; CDS981958I , Lot Number 20IBD365 ; CDS981978J , Lot Number 22ABS129 ; CDS981978J , Lot Number 22BBW393 ; CDS981978J , Lot Number 22OBM375 ; CDS981978J , Lot Number 22DBE792 ; CDS981978J , Lot Number 22FBT440 ; CDS981978J , Lot Number 22GBP083 ; CDS981978J , Lot Number 22HBS542 ; CDS981978J , Lot Number 19HBE289 ; CDS981978J , Lot Number 19HBN029 ; CDS981978J , Lot Number 22KBS125 ; CDS981978J , Lot Number 23BBG739 ; CDS981978J , Lot Number 19KBZ001 ; CDS981978J , Lot Number 19LBU222 ; CDS981978J , Lot Number 23EBM504 ; CDS981978J , Lot Number 20BBQ333 ; CDS981978J , Lot Number 23HBD015 ; CDS981978J , Lot Number 23IBI896 ; CDS981978J , Lot Number 20EBV123 ; CDS981978J , Lot Number 23JBT303 ; CDS981978J , Lot Number 23KBJ612 ; CDS981978J , Lot Number 24ABB202 ; CDS981978J , Lot Number 20KBF396 ; CDS981978J , Lot Number 20KBG259 ; CDS981978J , Lot Number 20LBT139 ; CDS981978J , Lot Number 21DBI647 ; CDS981978J , Lot Number 21DBT956 ; CDS981978J , Lot Number 21EBH609 ; CDS982018K , Lot Number 21GBP350 ; CDS982018K , Lot Number 21IBP808 ; CDS982018K , Lot Number 21JBN498 ; CDS982018K , Lot Number 21DBA517 ; CDS982018K , Lot Number 21DBJ935 ; CDS982038S , Lot Number 19IDC120 ; CDS982038S , Lot Number 19IDC919 ; CDS982038S , Lot Number 19JDC530 ; CDS982038S , Lot Number 20BDA460 ; CDS982038S , Lot Number 20DDB470 ; CDS982038S , Lot Number 20EDB148 ; CDS982038S , Lot Number 20EDC015 ; CDS982042O , Lot Number 21KBZ606 ; CDS982042O , Lot Number 21KBZ607 ; CDS982042O , Lot Number 22GBL942 ; CDS982042O , Lot Number 22GBU465 ; CDS982042O , Lot Number 22IBA637 ; CDS982042O , Lot Number 22IBB277 ; CDS982053M , Lot Number 19CDA667 ; CDS982053M , Lot Number 19EDB236 ; CDS982053M , Lot Number 19GDA076 ; CDS982053N , Lot Number 19IDA079 ; CDS982053N , Lot Number 19IDB876 ; CDS982053N , Lot Number 19KDA807 ; CDS982053N , Lot Number 20ADB575 ; CDS982053N , Lot Number 20BDB159 ; CDS982053N , Lot Number 20CDB174 ; CDS982053N , Lot Number 20EDB255 ; CDS982053N , Lot Number 20FDA306 ; CDS982053N , Lot Number 20LDA473 ; CDS982053N , Lot Number 21CDB461 ; 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CDS983639G , Lot Number 21ABO331 ; CDS983639I , Lot Number 21GBS671 ; CDS983639I , Lot Number 21VBA239 ; CDS983639I , Lot Number 22BBY281 ; CDS983639I , Lot Number 22DBM042 ; CDS983639I , Lot Number 22EBE644 ; CDS983639I , Lot Number 22FBP775 ; CDS983639I , Lot Number 21DBA540 ; CDS983639I , Lot Number 21DBQ406 ; CDS983639I , Lot Number 21EBK787 ; CDS983639J , Lot Number 22IBF004 ; CDS983639J , Lot Number 22IBF012 ; CDS983639J , Lot Number 22KBK687 ; CDS983639J , Lot Number 22LBE960 ; CDS983639K , Lot Number 23CBV828 ; CDS983639K , Lot Number 23EBA182 ; CDS983639K , Lot Number 23EBN996 ; CDS983639K , Lot Number 23FBH151 ; CDS983639K , Lot Number 23FBP157 ; CDS983639K , Lot Number 23GBM569 ; CDS983660C , Lot Number 19DDC061 ; CDS983660C , Lot Number 19HDA720 ; CDS983660C , Lot Number 19JDA745 ; CDS983660C , Lot Number 19JDC355 ; CDS983660C , Lot Number 19LDA802 ; CDS983660D , Lot Number 20BDB913 ; CDS983660D , Lot Number 20EDA669 ; CDS983660D , Lot Number 20JDD397 ; CDS983660D , Lot Number 21ADB687 ; CDS983660F , Lot Number 21CDC547 ; CDS983660G , Lot Number 22HBA388 ; CDS983660G , Lot Number 22HBQ513 ; CDS983660G , Lot Number 22HBS541 ; CDS983660G , Lot Number 22IBR079 ; CDS983660G , Lot Number 22LBO866 ; CDS983660G , Lot Number 23BBN799 ; CDS983660G , Lot Number 23EBJ318 ; CDS983660G , Lot Number 23GBG715 ; CDS983660G , Lot Number 24ABG785 ; CDS983660G , Lot Number 24ABT070 ; CDS983660G , Lot Number 24BBO561 ; CDS983660G , Lot Number 21HDA472 ; CDS983660G , Lot Number 21IDB899 ; CDS983720I , Lot Number 19ABV456 ; CDS983720I , Lot Number 19CBS628 ; CDS983720I , Lot Number 19FBK088 ; CDS983720I , Lot Number 19HBA157 ; CDS983720J , Lot Number 21FBN797 ; CDS983720J , Lot Number 21HBP953 ; CDS983720J , Lot Number 21KBV832 ; CDS983720J , Lot Number 22BBP016 ; CDS983720J , Lot Number 22BBP017 ; CDS983720J , Lot Number 22BBW509 ; CDS983720J , Lot Number 22EBU136 ; CDS983720J , Lot Number 22HBC069 ; CDS983720J , Lot Number 19TBB891 ; CDS983720J , Lot Number 22KBT157 ; CDS983720J , Lot Number 22KBT993 ; CDS983720J , Lot Number 19VBG327 ; CDS983720J , Lot Number 23BBA893 ; CDS983720J , Lot Number 23BBB026 ; CDS983720J , Lot Number 23CBN905 ; CDS983720J , Lot Number 23EBG032 ; CDS983720J , Lot Number 20BBH287 ; CDS983720J , Lot Number 23FBB356 ; CDS983720J , Lot Number 20BBZ103 ; CDS983720J , Lot Number 23GBA948 ; CDS983720J , Lot Number 23GBN730 ; CDS983720J , Lot Number 20EBF652 ; CDS983720J , Lot Number 23IBD346 ; CDS983720J , Lot Number 23JBF538 ; CDS983720J , Lot Number 20GBB718 ; CDS983720J , Lot Number 23KBF595 ; CDS983720J , Lot Number 23LBV017 ; CDS983720J , Lot Number 20IBL286 ; CDS983720J , Lot Number 20IBR104 ; CDS983720J , Lot Number 20JBI715 ; CDS983720J , Lot Number 20JBU133 ; CDS983720J , Lot Number 21BBI306 ; CDS983787C , Lot Number 21EMA513 ; CDS983787C , Lot Number 21GMB655 ; CDS983787C , Lot Number 21IMB723 ; CDS983787C , Lot Number 21IMG023 ; CDS983787C , Lot Number 21JME460 ; CDS983787C , Lot Number 22AME252 ; CDS983787C , Lot Number 22DMC312 ; CDS983787C , Lot Number 22FMG586 ; CDS983787C , Lot Number 22GMC280 ; CDS983787C , Lot Number 22HMC723 ; CDS983787C , Lot Number 22LME799 ; CDS983787C , Lot Number 23DMI157 ; CDS983787C , Lot Number 23EMH183 ; CDS983787C , Lot Number 23GMD406 ; CDS983787C , Lot Number 23HMB792 ; CDS983787C , Lot Number 23JMJ197 ; CDS983787C , Lot Number 24AMG008 ; CDS983787C , Lot Number 19BKB623 ; CDS983787C , Lot Number 19EKA120 ; CDS983787C , Lot Number 19FKA608 ; CDS983787C , Lot Number 19GKA276 ; CDS983787C , Lot Number 19HKC574 ; CDS983787C , Lot Number 20AKA356 ; CDS983787C , Lot Number 20AKB597 ; CDS983787C , Lot Number 20CKA676 ; CDS983787C , Lot Number 20EKA289 ; CDS983787C , Lot Number 20GKA529 ; CDS983787C , Lot Number 20HKA858 ; CDS983787C , Lot Number 20IKA629 ; CDS983787C , Lot Number 20JKB057 ; CDS983787C , Lot Number 20KKB439 ; CDS983787C , Lot Number 21CKA662 ; CDS983880D , Lot Number 23IBA324 ; CDS983880D , Lot Number 23IBG227 ; CDS983880D , Lot Number 23JBF723 ; CDS983880D , Lot Number 23JBL892 ; CDS983880D , Lot Number 23JBT843 ; CDS983880D , Lot Number 23KBD268 ; CDS983880D , Lot Number 23KBP677 ; CDS983880D , Lot Number 23LBM395 ; CDS983880D , Lot Number 23LBO232 ; CDS983880D , Lot Number 24ABW361 ; CDS983996B , Lot Number 19BBH113 ; CDS983996B , Lot Number 19CBA985 ; CDS983996B , Lot Number 22GBK836 ; CDS983996B , Lot Number 22JBM476 ; CDS983996B , Lot Number 19IBJ434 ; CDS983996B , Lot Number 19JBS461 ; CDS983996B , Lot Number 23ABG006 ; CDS983996B , Lot Number 20BBU847 ; CDS983996B , Lot Number 23HBG686 ; CDS983996B , Lot Number 23IBH029 ; CDS983996B , Lot Number 20GBD829 ; CDS983996B , Lot Number 20HBD634 ; CDS983996B , Lot Number 20HBQ701 ; CDS983996B , Lot Number 20IBF819 ; CDS983996B , Lot Number 20JBB851 ; CDS983996B , Lot Number 20KBQ351 ; CDS983996B , Lot Number 20WBC030 ; CDS983997B , Lot Number 19BBN590 ; CDS983997B , Lot Number 19CBA986 ; CDS983997B , Lot Number 19GBP136 ; CDS983997B , Lot Number 19JBA352 ; CDS983997B , Lot Number 19VBE343 ; CDS983997B , Lot Number 23ABU303 ; CDS983997B , Lot Number 23BBD093 ; CDS983997B , Lot Number 23CBO728 ; CDS983997B , Lot Number 20DBH030 ; CDS983997B , Lot Number 23HBM158 ; CDS983997B , Lot Number 20JBH080 ; CDS983997B , Lot Number 20KBA328 ; CDS983999B , Lot Number 21JBF862 ;

Distribution pattern

Worldwide distribution.

device · product 37 of 81

Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D

Z-3017-2024
Recall number
Z-3017-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ03097D, Lot Number 21JBV108; DYNJ03097D, Lot Number 22DBE716

Distribution pattern

Worldwide distribution.

device · product 38 of 81

Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ0259872M ; 4) EYE BASIN PACK-LF , Pack Number DYNJ0259872MH; 5) BASIN DBL PACK-LF , Pack Number DYNJ0287720N ; 6) PRMC BASIN SET UP PACK-LF , Pack Number DYNJ0321828Q ; 7) PRMC BASIN SET UP PACK-LF , Pack Number DYNJ0321828R ; 8) STANDARD BASIN PACK-LF, Pack Number DYNJ0420605J ; 9) MINOR BASIN PACK-LF , Pack Number DYNJ0515988L ; 10) MINOR BASIN PACK-LF , Pack Number DYNJ0515988M ; 11) MAJOR BASIN PACK-LF , Pack Number DYNJ0515994Q ; 12) MAJOR BASIN SET-LF, Pack Number DYNJ0551335Q ; 13) MINOR BASIN PACK-LF , Pack Number DYNJ0551725M ; 14) MINOR BASIN PACK, Pack Number DYNJ0557071D ; 15) UROLOGY BASIN PACK-LF , Pack Number DYNJ0561216G ; 16) LAKELAND SINGLE BASIN PACK-LF , Pack Number DYNJ0619907I ; 17) LAKELAND SINGLE BASIN PACK-LF , Pack Number DYNJ0619907K ; 18) LKLND SNGL BASIN PK RFID-LF , Pack Number DYNJ0619907L ; 19) OPEN HEART C--BASIN PACK-LF, Pack Number DYNJ0867331G; 20) OPEN HEART C--BASIN PACK-LF, Pack Number DYNJ0867331I; 21) TOTAL KNEE BASIN B PACK-LF, Pack Number DYNJ0867555L ; 22) VAG DELIVERY BASIN-LF , Pack Number DYNJ16162I ; 23) MAJOR BASIN PACK, Pack Number DYNJ16629F ; 24) GENERAL BASIN PACK, Pack Number DYNJ16731J ; 25) ST. ANNE'S MINOR BASIN PACK , Pack Number DYNJ24622K ; 26) ST. ANNE'S MAJOR BASIN SET UP , Pack Number DYNJ24628M ; 27) B.A.P BASIN PACK, Pack Number DYNJ28855C ; 28) MAJOR PK W/BASIN MARYVIEW-LF, Pack Number DYNJ30506L ; 29) GYN LAPAROSCOPIC, Pack Number DYNJ31939D ; 30) MAJOR BASIN KIT , Pack Number DYNJ33438G ; 31) BASIN SET , Pack Number DYNJ33967D ; 32) MINOR BASIN PACK-LF , Pack Number DYNJ34575D ; 33) MINOR GEN BASIN PK 9128188-LF , Pack Number DYNJ35972L ; 34) BASIN PACK-LF , Pack Number DYNJ36419D ; 35) MINOR SINGLE BASIN PACK , Pack Number DYNJ37698K ; 36) MINOR SINGLE BASIN PACK , Pack Number DYNJ37698L ; 37) CVG BASIN PACK SC , Pack Number DYNJ38052G ; 38) NEURO BASIN PACK-LF , Pack Number DYNJ39461J ; 39) HEART BASIN TRAY, Pack Number DYNJ44396I ; 40) BASIN PACK, Pack Number DYNJ44706F ; 41) ARTHROSCOPY BASIN SET-LF, Pack Number DYNJ47944D ; 42) ARTHROSCOPY BASIN SET-LF, Pack Number DYNJ47944F ; 43) ORTHOPEDIC CUSTOM BASIN SET , Pack Number DYNJ47991J ; 44) ORTHOPEDIC CUSTOM BASIN SET , Pack Number DYNJ47991N ; 45) RMC BASIN PACK, Pack Number DYNJ48643K ; 46) RMC BASIN PACK, Pack Number DYNJ48643L ; 47) OPEN HEART BASIN PACK-6214, Pack Number DYNJ49530B ; 48) ROBOTIC BASIN PACK, Pack Number DYNJ49536B ; 49) MINOR BASIN PACK, Pack Number DYNJ50463D ; 50) MAJOR BASIN PACK, Pack Number DYNJ50464D ; 51) CSC-N TOWEL SET UP PACK , Pack Number DYNJ50876A ; 52) BASIN SET , Pack Number DYNJ50906F ; 53) PK-SET UP-LF, Pack Number DYNJ51808B ; 54) DOUBLE BASIN OR SET , Pack Number DYNJ51940C ; 55) TR-MINOR KIT-LF , Pack Number DYNJ54801D ; 56) TR-MINOR KIT-LF , Pack Number DYNJ54801F ; 57) TR-MINOR KIT-LF, Pack Number DYNJ54801F ; 58) MAJOR PACK, Pack Number DYNJ55895C ; 59) ORTHO PACK, Pack Number DYNJ55896C ; 60) LITHOTOMY PACK, Pack Number DYNJ55900C ; 61) LAMINECTOMY-DISCECTOMY PACK , Pack Number DYNJ57263B ; 62) BASIN PACK, Pack Number DYNJ57465D ; 63) MAJOR BASIN PACK, Pack Number DYNJ57928C ; 64) PK-MAD,SPINE, Pack Number DYNJ58060I ; 65) SINGLE BASIN PACK-LF, Pack Number DYNJ58389D ; 66) SINGLE BASIN PACK-LF, Pack Number DYNJ58389F ; 67) MINOR SINGLE BASIN-LF , Pack Number DYNJ59649A ; 68) MAJOR BASIN PACK, Pack Number DYNJ59816A ; 69) FLAP PACK , Pack Number DYNJ60224C ; 70) FLAP PACK, Pack Number DYNJ60224D; 71) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529A ; 72) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529B ; 73) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529C ; 74) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529D ; 75) AV FISTULA, Pack Number DYNJ60614C ; 76) BASIN PACK, Pack Number

Z-3018-2024
Recall number
Z-3018-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ0100999K , Lot Number 23CDA712 ; DYNJ0100999K , Lot Number 23FDB897 ; DYNJ0100999K , Lot Number 23KDA691 ; DYNJ0100999K , Lot Number 23LDB403 ; DYNJ0154061C , Lot Number 23KBT382 ; DYNJ0154061C , Lot Number 23LBT241 ; DYNJ0154061C , Lot Number 23EMD583 ; DYNJ0154061C , Lot Number 23FME877 ; DYNJ0154061C , Lot Number 23GMB699 ; DYNJ0154061C , Lot Number 23GMI468 ; DYNJ0259872M , Lot Number 23FMG803 ; DYNJ0259872M , Lot Number 23HMB007 ; DYNJ0259872MH, Lot Number 23FMG803 ; DYNJ0259872MH, Lot Number 23HMB007 ; DYNJ0287720N , Lot Number 23EMG655 ; DYNJ0287720N , Lot Number 23FMF756 ; DYNJ0287720N , Lot Number 23JMI005 ; DYNJ0287720N , Lot Number 23KMA793 ; DYNJ0321828Q , Lot Number 23AMB499 ; DYNJ0321828Q , Lot Number 23BMC189 ; DYNJ0321828Q , Lot Number 23CMD749 ; DYNJ0321828R , Lot Number 23GMI651 ; DYNJ0321828R , Lot Number 23JMA448 ; DYNJ0321828R , Lot Number 23JMH652 ; DYNJ0321828R , Lot Number 23KMI549 ; DYNJ0321828R , Lot Number 23LMF228 ; DYNJ0420605J , Lot Number 23EMF416 ; DYNJ0420605J , Lot Number 23GMA095 ; DYNJ0420605J , Lot Number 23HMB535 ; DYNJ0420605J , Lot Number 23JMD757 ; DYNJ0420605J , Lot Number 23KMJ720 ; DYNJ0420605J , Lot Number 23LMH673 ; DYNJ0515988L , Lot Number 23EMH495 ; DYNJ0515988L , Lot Number 23FMI244 ; DYNJ0515988L , Lot Number 23HMC118 ; DYNJ0515988M , Lot Number 23JMG254 ; DYNJ0515994Q , Lot Number 22KME301 ; DYNJ0551335Q , Lot Number 23LBB635 ; DYNJ0551725M , Lot Number 23KBQ890 ; DYNJ0551725M , Lot Number 23EMG101 ; DYNJ0551725M , Lot Number 23FMH707 ; DYNJ0557071D , Lot Number 23BDB036 ; DYNJ0557071D , Lot Number 23EDC281 ; DYNJ0557071D , Lot Number 23IDA197 ; DYNJ0557071D , Lot Number 23JDA757 ; DYNJ0557071D , Lot Number 23KDB079 ; DYNJ0557071D , Lot Number 23LDB880 ; DYNJ0561216G , Lot Number 23HDA699 ; DYNJ0561216G , Lot Number 23HDB167 ; DYNJ0561216G , Lot Number 23JDB974 ; DYNJ0561216G , Lot Number 23KDB226 ; DYNJ0619907I , Lot Number 22IMG033 ; DYNJ0619907K , Lot Number 22LME111 ; DYNJ0619907L , Lot Number 23HBV761 ; DYNJ0619907L , Lot Number 23JBH171 ; DYNJ0619907L , Lot Number 23KBA590 ; DYNJ0619907L , Lot Number 23LBO409 ; DYNJ0619907L , Lot Number 23CMC041 ; DYNJ0619907L , Lot Number 23EMB088 ; DYNJ0619907L , Lot Number 23FMI052 ; DYNJ0867331G, Lot Number 22FDA407; DYNJ0867331G, Lot Number 22EDA376; DYNJ0867331I, Lot Number 23JDC480; DYNJ0867331I, Lot Number 23IDB379; DYNJ0867331I, Lot Number 23HDB881; DYNJ0867331I, Lot Number 23EDB344; DYNJ0867331I, Lot Number 22LDA905; DYNJ0867331I, Lot Number 22IDB226; DYNJ0867555L , Lot Number 22IDA191 ; DYNJ0867555L , Lot Number 22IDB859 ; DYNJ0867555L , Lot Number 22JDA741 ; DYNJ0867555L , Lot Number 22JDB303 ; DYNJ0867555L , Lot Number 23BDB828 ; DYNJ0867555L , Lot Number 23CDA940 ; DYNJ0867555L , Lot Number 23CDB474 ; DYNJ0867555L , Lot Number 23DDB147 ; DYNJ0867555L , Lot Number 23FDB933 ; DYNJ0867555L , Lot Number 23IDA852 ; DYNJ0867555L , Lot Number 23IDB255 ; DYNJ16162I , Lot Number 24AMB598 ; DYNJ16629F , Lot Number 22FMF622 ; DYNJ16629F , Lot Number 22GMH882 ; DYNJ16629F , Lot Number 22IMC526 ; DYNJ16629F , Lot Number 22JMG093 ; DYNJ16629F , Lot Number 22KMF920 ; DYNJ16629F , Lot Number 23AME322 ; DYNJ16629F , Lot Number 23CMA865 ; DYNJ16629F , Lot Number 23DMD321 ; DYNJ16629F , Lot Number 23EMC896 ; DYNJ16629F , Lot Number 23EMJ236 ; DYNJ16629F , Lot Number 23FMI093 ; DYNJ16629F , Lot Number 23HMD345 ; DYNJ16629F , Lot Number 23JMD231 ; DYNJ16629F , Lot Number 23KMG706 ; DYNJ16731J , Lot Number 22EMI309 ; DYNJ16731J , Lot Number 22GMD773 ; DYNJ16731J , Lot Number 22IMF226 ; DYNJ16731J , Lot Number 22LME858 ; DYNJ16731J , Lot Number 23AMH984 ; DYNJ16731J , Lot Number 23CME198 ; DYNJ16731J , Lot Number 23FMB867 ; DYNJ16731J , Lot Number 23FMH281 ; DYNJ16731J , Lot Number 23GMI249 ; DYNJ16731J , Lot Number 23JMC896 ; DYNJ16731J , Lot Number 23JMJ344 ; DYNJ16731J , Lot Number 23LMB438 ; DYNJ16731J , Lot Number 24AMA832 ; DYNJ24622K , Lot Number 22EBE400 ; DYNJ24622K , Lot Number 22EBS282 ; DYNJ24622K , Lot Number 22GBG590 ; DYNJ24622K , Lot Number 22GBS539 ; DYNJ24622K , Lot Number 22IBS562 ; DYNJ24622K , Lot Number 22JBG476 ; DYNJ24622K , Lot Number 22JBY151 ; DYNJ24622K , Lot Number 22KBV541 ; DYNJ24622K , Lot Number 23ABN514 ; DYNJ24622K , Lot Number 23BBQ883 ; DYNJ24622K , Lot Number 23CBH097 ; DYNJ24622K , Lot Number 23CBV810 ; DYNJ24622K , Lot Number 23EBT659 ; DYNJ24622K , Lot Number 23HBG570 ; DYNJ24628M , Lot Number 22CLB278 ; DYNJ24628M , Lot Number 22DLA993 ; DYNJ24628M , Lot Number 22FLA375 ; DYNJ24628M , Lot Number 22GLA608 ; DYNJ24628M , Lot Number 22HLA605 ; DYNJ24628M , Lot Number 22ILA590 ; DYNJ24628M , Lot Number 22JLA323 ; DYNJ24628M , Lot Number 22KLA301 ; DYNJ24628M , Lot Number 23ALA246 ; DYNJ24628M , Lot Number 23BLA536 ; DYNJ24628M , Lot Number 23CLB087 ; DYNJ24628M , Lot Number 23DLA800 ; DYNJ24628M , Lot Number 23FLA366 ; DYNJ24628M , Lot Number 23GLA918 ; DYNJ28855C , Lot Number 23ABD220 ; DYNJ28855C , Lot Number 23GBQ608 ; DYNJ30506L , Lot Number 22EBS899 ; DYNJ30506L , Lot Number 22FBM852 ; DYNJ30506L , Lot Number 22HBG080 ; DYNJ30506L , Lot Number 22HBI572 ; DYNJ30506L , Lot Number 22JBW507 ; DYNJ30506L , Lot Number 22LBO454 ; DYNJ30506L , Lot Number 23ABG721 ; DYNJ30506L , Lot Number 23BBQ915 ; DYNJ30506L , Lot Number 23DBB759 ; DYNJ30506L , Lot Number 23DBC331 ; DYNJ30506L , Lot Number 23EBW305 ; DYNJ30506L , Lot Number 23GBQ469 ; DYNJ30506L , Lot Number 23IBH276 ; DYNJ30506L , Lot Number 23JBP540 ; DYNJ30506L , Lot Number 23LBK774 ; DYNJ31939D , Lot Number 22EBG755 ; DYNJ31939D , Lot Number 22FBV121 ; DYNJ31939D , Lot Number 22HBT653 ; DYNJ31939D , Lot Number 22JBG337 ; DYNJ31939D , Lot Number 23ABH680 ; DYNJ33438G , Lot Number 23JBW584 ; DYNJ33438G , Lot Number 23LBJ169 ; DYNJ33967D , Lot Number 23DBO130 ; DYNJ33967D , Lot Number 23GBF213 ; DYNJ33967D , Lot Number 23HBA412 ; DYNJ34575D , Lot Number 24AMB562 ; DYNJ35972L , Lot Number 22DDA624 ; DYNJ35972L , Lot Number 22FDB007 ; DYNJ35972L , Lot Number 22HDA162 ; DYNJ35972L , Lot Number 22HDC210 ; DYNJ35972L , Lot Number 22JDB968 ; DYNJ35972L , Lot Number 23ADA549 ; DYNJ35972L , Lot Number 23CDA646 ; DYNJ35972L , Lot Number 23DDA321 ; DYNJ35972L , Lot Number 23EDA880 ; DYNJ35972L , Lot Number 23FDC076 ; DYNJ35972L , Lot Number 23GDC117 ; DYNJ35972L , Lot Number 23IDC296 ; DYNJ35972L , Lot Number 23KDA056 ; DYNJ35972L , Lot Number 23LDB098 ; DYNJ35972L , Lot Number 24BDA962 ; DYNJ36419D , Lot Number 23DBB198 ; DYNJ36419D , Lot Number 23FBT396 ; DYNJ36419D , Lot Number 23HBL079 ; DYNJ36419D , Lot Number 23JBD190 ; DYNJ36419D , Lot Number 23KBF891 ; DYNJ37698K , Lot Number 23DMG367 ; DYNJ37698K , Lot Number 23EMI659 ; DYNJ37698L , Lot Number 23FMJ157 ; DYNJ37698L , Lot Number 23HMH663 ; DYNJ37698L , Lot Number 23IMD943 ; DYNJ37698L , Lot Number 23KMG076 ; DYNJ37698L , Lot Number 24AMA944 ; DYNJ38052G , Lot Number 22CBX946 ; DYNJ38052G , Lot Number 22DBE259 ; DYNJ38052G , Lot Number 22EBB509 ; DYNJ38052G , Lot Number 22GBU984 ; DYNJ38052G , Lot Number 22IBP839 ; DYNJ38052G , Lot Number 23EBM695 ; DYNJ38052G , Lot Number 23FBO284 ; DYNJ38052G , Lot Number 23KBO599 ; DYNJ38052G , Lot Number 23LBJ194 ; DYNJ38052G , Lot Number 23LBN771 ; 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DYNJ905735D, Lot Number 22JMG541 ; DYNJ905735D, Lot Number 22LMD828 ; DYNJ905735G, Lot Number 23IMA249 ; DYNJ905735G, Lot Number 23IMC285 ; DYNJ905735G, Lot Number 23KMA289 ; DYNJ905735G, Lot Number 23LMD486 ; DYNJ905735G, Lot Number 23LMG064 ; DYNJ905735I, Lot Number 23LMG551 ; DYNJ905735I, Lot Number 24AMF747 ; DYNJ905735I, Lot Number 24AMG467 ; DYNJ905736D, Lot Number 22FMI415 ; DYNJ905736D, Lot Number 22GMA656 ; DYNJ905736D, Lot Number 22HMC460 ; DYNJ905736D, Lot Number 22IMB491 ; DYNJ905736D, Lot Number 22IMF920 ; DYNJ905736D, Lot Number 22IMH583 ; DYNJ905736D, Lot Number 22JME460 ; DYNJ905736D, Lot Number 23AMF585 ; DYNJ905736F, Lot Number 23EME754 ; DYNJ905736F, Lot Number 23FMD723 ; DYNJ905736F, Lot Number 23FMJ369 ; DYNJ905736G, Lot Number 23HMG050 ; DYNJ905736G, Lot Number 23HMI859 ; DYNJ905736G, Lot Number 23IMH788 ; DYNJ905736G, Lot Number 23KMG357 ; DYNJ905736G, Lot Number 23LMH066 ; DYNJ905736I, Lot Number 24AMF901 ; DYNJ905738D, Lot Number 22IMD571 ; DYNJ905738D, Lot Number 22IMF719 ; DYNJ905738D, Lot Number 22IMH149 ; DYNJ905738F, Lot Number 23CME113 ; DYNJ905738F, Lot Number 23CMG070 ; DYNJ905738F, Lot Number 23DMC887 ; DYNJ905738F, Lot Number 23EMD703 ; DYNJ905738F, Lot Number 23FME825 ; DYNJ905738G, Lot Number 23HMH026 ; DYNJ905738G, Lot Number 23KMF334 ; DYNJ905738I, Lot Number 24AME660 ; DYNJ905740D, Lot Number 22JMA202 ; DYNJ905740F, Lot Number 23CME525 ; DYNJ905740F, Lot Number 23CMG977 ; DYNJ905740F, Lot Number 23EMH896 ; DYNJ905740F, Lot Number 23FMF990 ; DYNJ905740F, Lot Number 23GMC788 ; DYNJ905740F, Lot Number 23GME972 ; DYNJ905740G, Lot Number 23HMI270 ; DYNJ905740G, Lot Number 23KMA291 ; DYNJ905740G, Lot Number 23LMA958 ; DYNJ905741D, Lot Number 22GMA264 ; DYNJ905741D, Lot Number 22HMB892 ; DYNJ905741D, Lot Number 22JMC779 ; DYNJ905741F, Lot Number 23FME349 ; DYNJ905741F, Lot Number 23GMA273 ; DYNJ905741G, Lot Number 23HMI322 ; DYNJ905741G, Lot Number 23JMB336 ; DYNJ905741G, Lot Number 23KMH134 ; DYNJ905741G, Lot Number 23LMA175 ; DYNJ906136G, Lot Number 22LDB002 ; DYNJ906136I, Lot Number 23GDB794 ; DYNJ906136I, Lot Number 23IDB424 ; DYNJ906531B, Lot Number 22GMA271 ; DYNJ906531B, Lot Number 22HMC455 ; DYNJ906531B, Lot Number 22IMB495 ; DYNJ906531B, Lot Number 23AMC129 ; DYNJ906531B, Lot Number 23BMB889 ; DYNJ906531B, Lot Number 23CMA027 ; DYNJ906531B, Lot Number 23CMB202 ; DYNJ906531C, Lot Number 23CMF414 ; DYNJ906531C, Lot Number 23DME063 ; DYNJ906531C, Lot Number 23DMG660 ; DYNJ906531C, Lot Number 23EMD704 ; DYNJ906531C, Lot Number 23FMJ637 ; DYNJ906531D, Lot Number 23HMD457 ; DYNJ906531D, Lot Number 23IMF858 ; DYNJ906531D, Lot Number 23JMB959 ; DYNJ906531D, Lot Number 23KMG358 ; DYNJ906531D, Lot Number 23LMH079 ; DYNJ907808A, Lot Number 21IBF029 ; DYNJ907808A, Lot Number 21LBM197 ; DYNJ907808A, Lot Number 22BBU558 ; DYNJ907808A, Lot Number 22CBU903 ; DYNJ907808A, Lot Number 22DBM684 ; DYNJ907808A, Lot Number 22DBS362 ; DYNJ907808A, Lot Number 22DBU023 ; DYNJ907808A, Lot Number 22EBE779 ; DYNJ907808A, Lot Number 22GBB171 ; DYNJ907808A, Lot Number 22HBF098 ; DYNJ907808A, Lot Number 22IBT348 ; DYNJ907808B, Lot Number 22IBS662 ; DYNJ907808B, Lot Number 22IBV340 ; DYNJ907808B, Lot Number 22JBA257 ; DYNJ907808B, Lot Number 22JBU478 ; DYNJ907808B, Lot Number 23ABC225 ; DYNJ907808B, Lot Number 23ABE691 ; DYNJ907808B, Lot Number 23BBG710 ; DYNJ907808B, Lot Number 23BBL753 ; DYNJ907808B, Lot Number 23DBL278 ; DYNJ907808B, Lot Number 23FBE551 ; DYNJ907808B, Lot Number 23GBH158 ; DYNJ907808B, Lot Number 23HBQ507 ; DYNJ907808B, Lot Number 23JBA903 ; DYNJ907808B, Lot Number 23JBE446 ; DYNJ907808B, Lot Number 23KBT045 ; DYNJ907808B, Lot Number 24ABE299 ; DYNJ907808B, Lot Number 24BBM054 ; DYNJ908472A, Lot Number 22FMI042 ; DYNJ908472A, Lot Number 22GMH043 ; DYNJ908472A, Lot Number 22HMD595 ; DYNJ908472A, Lot Number 22IMH906 ; DYNJ908472A, Lot Number 22JMG252 ; DYNJ908472A, Lot Number 22KMC697 ; DYNJ908472A, Lot Number 22LMI898 ; DYNJ908472A, Lot Number 23BMF093 ; DYNJ908472B, Lot Number 23FME720 ; DYNJ908472B, Lot Number 23FMJ790 ; DYNJ908472B, Lot Number 23HMC089 ; DYNJ908472B, Lot Number 23IMH409 ; DYNJ908472B, Lot Number 23LMC860 ; DYNJ908472B, Lot Number 24AMC465 ; DYNJ908483A, Lot Number 22GMG188 ; DYNJ908483A, Lot Number 22HMA818 ; DYNJ908483A, Lot Number 22KMG635 ; DYNJ908483B, Lot Number 23BMF105 ; DYNJ908483B, Lot Number 23CMB395 ; DYNJ908483B, Lot Number 23FMB021 ; DYNJ908483C, Lot Number 23FME722 ; DYNJ908483C, Lot Number 23FMH321 ; DYNJ908483C, Lot Number 23GMD479 ; DYNJ908483C, Lot Number 23HMB823 ; DYNJ908483C, Lot Number 23HME147 ; DYNJ908483C, Lot Number 23IMH859 ; DYNJ908483C, Lot Number 23JMC583 ; DYNJ908483C, Lot Number 23JMI184 ; DYNJ908483C, Lot Number 23LMC861 ; DYNJ908483C, Lot Number 23LMH271 ; DYNJ909509 , Lot Number 23GMC783 ; DYNJ909509 , Lot Number 23KMC377 ; DYNJ909509 , Lot Number 23KMF388 ; DYNJ909785 , Lot Number 23HBU592 ; DYNJ909785 , Lot Number 23IBN694 ; DYNJ909785 , Lot Number 23LBP759 ; DYNJ909785 , Lot Number 24ABN452 ; DYNJ909787 , Lot Number 23IBK777 ; DYNJ909787 , Lot Number 24ABD903 ; DYNJ909787 , Lot Number 24ABW364 ; DYNJ909843 , Lot Number 23JMD324 ; DYNJRA2193 , Lot Number 23GBU790 ; DYNJRA2193 , Lot Number 23JBC754 ; PHS619928002C, Lot Number 22KMF407 ; PHS619928002C, Lot Number 22LMB206 ; PHS619928002C, Lot Number 23BMB346

Distribution pattern

Worldwide distribution.

device · product 39 of 81

Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ; 6) PROCEDURE PACK-LF , Pack Number 00-401585M ; 7) PTCA PACK , Pack Number 00-401800F ; 8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ; 9) PICC LINE TRAY, Pack Number 00-401993N ; 10) ARTERIOGRAM TRAY, Pack Number 00-402001S ; 11) CARDIAC CATH PACK , Pack Number 00-500502L ; 12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N; 13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O; 14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P; 15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672; 16) KIT ANGIO CSTM, Pack Number 135169; 17) KIT NEURO 2-UIC, Pack Number 138557; 18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ; 19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356; 20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1; 21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ; 22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ; 23) PROCEDURAL ACC KIT, Pack Number 20060921 ; 24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ; 25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ; 26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ; 27) BASIC PROCEDURE PACK, Pack Number 7790 ; 28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ; 29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ; 30) PROCEDURE PACK, RF, Pack Number 7795 ; 31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ; 32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ; 33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ; 34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ; 35) NEONATAL DRAWER 6 , Pack Number ACC010653; 36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A; 37) RADIAL TRAY , Pack Number AM140A ; 38) RADIAL TRAY , Pack Number AM140B ; 39) SET UP TRAY , Pack Number AM235A ; 40) PACK SET UP , Pack Number AM235B ; 41) HEAD & NECK TRAY, Pack Number AM310A ; 42) 18GX6 FEMORAL ART MAX BARRIER KIT, Pack Number ART1230; 43) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 44) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 45) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110; 47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686; 48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710; 49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ; 50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ; 51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ; 52) CYSTO PROCEDURE , Pack Number CDS760062O ; 53) NEURO CDS , Pack Number CDS780056M ; 54) SHUNT CDS-LF, Pack Number CDS780103J ; 55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ; 56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ; 57) UVALDE C-SECTION CDS, Pack Number CDS820116D ; 58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ; 59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ; 60) AAA CDS , Pack Number CDS840076AB; 61) AAA CDS , Pack Number CDS840076X ; 62) AAA CDS , Pack Number CDS840076Y ; 63) OFF PUMP CABG CDS , Pack Number CDS840087AA; 64) OFF PUMP CABG CDS , Pack Number CDS840087AC; 65) OPEN HEART, Pack Number CDS840150Q ; 66) VALVE PACK, Pack Number CDS840187R ; 67) AV FISTULA PACK , Pack Number CDS840188L ; 68) MAJOR VASCULAR PACK , Pack Number CDS840195S ; 69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ; 70) FETOSCOPY CDS-LF, Pack Number CDS840215N ; 71) MAJOR VASCULAR-LF , Pack Number CDS840232J ; 72) AVF-LF, Pack Number CDS840233D ; 73) AVF-LF, Pack Number CDS840233F ; 74) AVF-LF, Pack Number CDS840233G ; 75) GENERAL AAA #11-RF, Pack Number CDS840261AA; 76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ; 77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ; 78) THOROCOTOMY , Pack Number CDS840354N ; 79) THOROCOTOMY , Pack Number CDS840354O ; 80) THORO

Z-3019-2024
Recall number
Z-3019-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

00-399025L , Lot Number 23LMB058 ; 00-399025L , Lot Number 23LMG684 ; 00-399025L , Lot Number 23LMH827 ; 00-399025L , Lot Number 24AMC410 ; 00-399025L , Lot Number 19ELA658 ; 00-399025L , Lot Number 19KLA410 ; 00-399025L , Lot Number 20BLA276 ; 00-399025L , Lot Number 20CLA517 ; 00-399025L , Lot Number 20GLA372 ; 00-399025L , Lot Number 20JLA514 ; 00-399025L , Lot Number 21ELA301 ; 00-399025L , Lot Number 21HLA415 ; 00-399025L , Lot Number 21JLA793 ; 00-399025L , Lot Number 22CLA145 ; 00-399025L , Lot Number 22ELA199 ; 00-399025L , Lot Number 22ELA628 ; 00-399025L , Lot Number 22JLA233 ; 00-399025L , Lot Number 23ALA823 ; 00-399025L , Lot Number 23ELA753 ; 00-399025L , Lot Number 23ELB229 ; 00-399025L , Lot Number 23JLA541 ; 00-399025L , Lot Number 23KLA374 ; 00-399227G , Lot Number 21FBH746 ; 00-399227G , Lot Number 21HBQ582 ; 00-399227G , Lot Number 21KBJ142 ; 00-399227G , Lot Number 21LBA848 ; 00-399227G , Lot Number 19ABX389 ; 00-399227G , Lot Number 22OBD945 ; 00-399227G , Lot Number 19FBF786 ; 00-399227G , Lot Number 19FBV846 ; 00-399227G , Lot Number 22HBG087 ; 00-399227G , Lot Number 19HBD311 ; 00-399227G , Lot Number 22JBP132 ; 00-399227G , Lot Number 19IBR526 ; 00-399227G , Lot Number 19KBL802 ; 00-399227G , Lot Number 23CBG549 ; 00-399227G , Lot Number 19LBY409 ; 00-399227G , Lot Number 20ABD605 ; 00-399227G , Lot Number 23FBQ709 ; 00-399227G , Lot Number 20CBV379 ; 00-399227G , Lot Number 23HBW465 ; 00-399227G , Lot Number 20EBL397 ; 00-399227G , Lot Number 20GBW360 ; 00-399227G , Lot Number 20JBJ256 ; 00-399227G , Lot Number 20VBB916 ; 00-399227G , Lot Number 21ABG945 ; 00-399227G , Lot Number 21EBA473 ; 00-399607N, Lot Number 24BME638; 00-399607N , Lot Number 21FBQ697 ; 00-399607N , Lot Number 21HBF930 ; 00-399607N , Lot Number 21IBK326 ; 00-399607N , Lot Number 21IBK327 ; 00-399607N , Lot Number 22BBP057 ; 00-399607N , Lot Number 19BBE379 ; 00-399607N , Lot Number 19BBG294 ; 00-399607N , Lot Number 22DBE564 ; 00-399607N , Lot Number 19DBF156 ; 00-399607N , Lot Number 19EBD546 ; 00-399607N , Lot Number 22FBI051 ; 00-399607N , Lot Number 19EBQ718 ; 00-399607N , Lot Number 19FBU662 ; 00-399607N , Lot Number 19GBL581 ; 00-399607N , Lot Number 22HBZ204 ; 00-399607N , Lot Number 22JBJ129 ; 00-399607N , Lot Number 19IBH297 ; 00-399607N , Lot Number 19IBZ735 ; 00-399607N , Lot Number 19VBC702 ; 00-399607N , Lot Number 19VBG151 ; 00-399607N , Lot Number 23ABS680 ; 00-399607N , Lot Number 19KBR370 ; 00-399607N , Lot Number 19KBW839 ; 00-399607N , Lot Number 19LBK459 ; 00-399607N , Lot Number 23DBR467 ; 00-399607N , Lot Number 23FBG342 ; 00-399607N , Lot Number 20BBX536 ; 00-399607N , Lot Number 23HBC816 ; 00-399607N , Lot Number 20DBN717 ; 00-399607N , Lot Number 23IBG758 ; 00-399607N , Lot Number 20FBF254 ; 00-399607N , Lot Number 23KBM922 ; 00-399607N , Lot Number 20HBO924 ; 00-399607N , Lot Number 20JBH212 ; 00-399607N , Lot Number 20XBI689 ; 00-399607N , Lot Number 21CBU874 ; 00-399607N , Lot Number 21DBB347 ; 00-399607N , Lot Number 23LMG018 ; 00-400616J , Lot Number 21JBQ238 ; 00-400616J , Lot Number 21KBM208 ; 00-400616J , Lot Number 21LBQ198 ; 00-400616J , Lot Number 21LBQ199 ; 00-400616J , Lot Number 19ABC535 ; 00-400616J , Lot Number 19ABQ477 ; 00-400616J , Lot Number 19BBT275 ; 00-400616J , Lot Number 19EBJ953 ; 00-400616J , Lot Number 22FBX768 ; 00-400616J , Lot Number 19GBA150 ; 00-400616J , Lot Number 22IBJ517 ; 00-400616J , Lot Number 22JBS696 ; 00-400616J , Lot Number 19IBJ031 ; 00-400616J , Lot Number 22KBS745 ; 00-400616J , Lot Number 22LBL785 ; 00-400616J , Lot Number 19JBT508 ; 00-400616J , Lot Number 19LBA785 ; 00-400616J , Lot Number 23CBX354 ; 00-400616J , Lot Number 23EBW479 ; 00-400616J , Lot Number 20BBR220 ; 00-400616J , Lot Number 20EBO092 ; 00-400616J , Lot Number 23JBA018 ; 00-400616J , Lot Number 23KBO018 ; 00-400616J , Lot Number 23LBJ675 ; 00-400616J , Lot Number 20LBI288 ; 00-400616J , Lot Number 20LBJ402 ; 00-400616J , Lot Number 20XBC223 ; 00-400616J , Lot Number 21CBN764 ; 00-400616J , Lot Number 21CBT581 ; 00-400616J , Lot Number 21EBF051 ; 00-400830S , Lot Number 23IBE843 ; 00-400830S , Lot Number 23IBI196 ; 00-400830S , Lot Number 23JBL301 ; 00-400830S , Lot Number 23KBI335 ; 00-400830S , Lot Number 24ABE342 ; 00-400830S , Lot Number 19JDC900 ; 00-400830S , Lot Number 19KMB409 ; 00-400830S , Lot Number 19LMB845 ; 00-400830S , Lot Number 20AMA452 ; 00-400830S , Lot Number 20BMC093 ; 00-400830S , Lot Number 20CMC351 ; 00-400830S , Lot Number 20CMC443 ; 00-400830S , Lot Number 20GMB539 ; 00-400830S , Lot Number 20HMC006 ; 00-400830S , Lot Number 20LMA673 ; 00-400830S , Lot Number 20LME457 ; 00-400830S , Lot Number 21BME605 ; 00-400830S , Lot Number 21DMD032 ; 00-400830S , Lot Number 21FME404 ; 00-400830S , Lot Number 21HMB981 ; 00-400830S , Lot Number 21IMB345 ; 00-400830S , Lot Number 21JMA926 ; 00-400830S , Lot Number 21KMH647 ; 00-400830S , Lot Number 22BMB219 ; 00-400830S , Lot Number 22CMD635 ; 00-400830S , Lot Number 22DMB287 ; 00-400830S , Lot Number 22FMA468 ; 00-400830S , Lot Number 22GMG716 ; 00-400830S , Lot Number 22IMC098 ; 00-400830S , Lot Number 22KMD166 ; 00-400830S , Lot Number 23AME191 ; 00-400830S , Lot Number 23CMD960 ; 00-400830S , Lot Number 23DMH465 ; 00-400830S , Lot Number 23FMC224 ; 00-401585M , Lot Number 19ABR824 ; 00-401585M , Lot Number 19DBP669 ; 00-401585M , Lot Number 19FBI427 ; 00-401585M , Lot Number 19FBO698 ; 00-401585M , Lot Number 19IBH054 ; 00-401585M , Lot Number 19LBD645 ; 00-401585M , Lot Number 20BBB119 ; 00-401585M , Lot Number 23IBJ823 ; 00-401585M , Lot Number 23LBL663 ; 00-401585M , Lot Number 20FMA061 ; 00-401585M , Lot Number 20JMC537 ; 00-401585M , Lot Number 20KMC440 ; 00-401585M , Lot Number 20LMD216 ; 00-401585M , Lot Number 20LMD921 ; 00-401585M , Lot Number 21FMC730 ; 00-401585M , Lot Number 21HMC720 ; 00-401585M , Lot Number 21LMA689 ; 00-401585M , Lot Number 22AMB433 ; 00-401585M , Lot Number 22EMA952 ; 00-401585M , Lot Number 22FMF861 ; 00-401585M , Lot Number 22JMH077 ; 00-401585M , Lot Number 23BMH392 ; 00-401585M , Lot Number 23EMC343 ; 00-401585M , Lot Number 23FMF240 ; 00-401800F , Lot Number 23KBJ336 ; 00-401824Y , Lot Number 19ABA463 ; 00-401824Y , Lot Number 19BBM632 ; 00-401824Y , Lot Number 19DBF545 ; 00-401824Y , Lot Number 19EBP557 ; 00-401824Y , Lot Number 19QBC013 ; 00-401824Y , Lot Number 19GBO308 ; 00-401824Y , Lot Number 19IBN215 ; 00-401824Y , Lot Number 20ABS313 ; 00-401824Y , Lot Number 20OBA225 ; 00-401824Y , Lot Number 20DBT822 ; 00-401824Y , Lot Number 20GBO557 ; 00-401824Y , Lot Number 20JBK032 ; 00-401824Y , Lot Number 20KBN921 ; 00-401824Y , Lot Number 21ABI762 ; 00-401993N , Lot Number 21GBQ640 ; 00-401993N , Lot Number 21IBF580 ; 00-401993N , Lot Number 21JBU044 ; 00-401993N , Lot Number 21VBA791 ; 00-401993N , Lot Number 21VBB237 ; 00-401993N , Lot Number 22ABN204 ; 00-401993N , Lot Number 19ABA852 ; 00-401993N , Lot Number 22BBP800 ; 00-401993N , Lot Number 19BBK028 ; 00-401993N , Lot Number 22CBZ966 ; 00-401993N , Lot Number 19DBH070 ; 00-401993N , Lot Number 22EBI940 ; 00-401993N , Lot Number 19FBA602 ; 00-401993N , Lot Number 19HBU668 ; 00-401993N , Lot Number 19UBB094 ; 00-401993N , Lot Number 22LBF683 ; 00-401993N , Lot Number 19JBT421 ; 00-401993N , Lot Number 23BBR801 ; 00-401993N , Lot Number 23CBQ612 ; 00-401993N , Lot Number 20ABA347 ; 00-401993N , Lot Number 20ABB319 ; 00-401993N , Lot Number 23FBL707 ; 00-401993N , Lot Number 23GBJ048 ; 00-401993N , Lot Number 20DBJ587 ; 00-401993N , Lot Number 20EBG102 ; 00-401993N , Lot Number 20FBT276 ; 00-401993N , Lot Number 20GBP559 ; 00-401993N , Lot Number 20JBS101 ; 00-401993N , Lot Number 20LBD910 ; 00-401993N , Lot Number 21ABF837 ; 00-401993N , Lot Number 21CBG009 ; 00-401993N , Lot Number 21DBP970 ; 00-402001S , Lot Number 19ABA654 ; 00-402001S , Lot Number 19BBP621 ; 00-402001S , Lot Number 19QBC409 ; 00-402001S , Lot Number 19HBM341 ; 00-402001S , Lot Number 19JBT480 ; 00-402001S , Lot Number 19KBY244 ; 00-402001S , Lot Number 20DBL145 ; 00-402001S , Lot Number 20FBG027 ; 00-402001S , Lot Number 20FBS826 ; 00-402001S , Lot Number 20GBV471 ; 00-402001S , Lot Number 20XBF495 ; 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CDS840215N , Lot Number 20CBC285 ; CDS840215N , Lot Number 20HBU126 ; CDS840215N , Lot Number 20VBA164 ; CDS840232J , Lot Number 19BBE444 ; CDS840232J , Lot Number 19DBW499 ; CDS840232J , Lot Number 19GBZ197 ; CDS840232J , Lot Number 19IBH929 ; CDS840232J , Lot Number 20BBA369 ; CDS840232J , Lot Number 20DBA252 ; CDS840233D , Lot Number 19BBE411 ; CDS840233D , Lot Number 19CBC676 ; CDS840233D , Lot Number 19DBT354 ; CDS840233D , Lot Number 19GBV606 ; CDS840233D , Lot Number 19HBM994 ; CDS840233D , Lot Number 20ABT105 ; CDS840233D , Lot Number 20ABV814 ; CDS840233D , Lot Number 20OBA122 ; CDS840233F , Lot Number 21GBV765 ; CDS840233F , Lot Number 20EBS090 ; CDS840233F , Lot Number 20GBH095 ; CDS840233F , Lot Number 20JBX502 ; CDS840233F , Lot Number 20LBF033 ; CDS840233F , Lot Number 20LBR765 ; CDS840233F , Lot Number 21BBB793 ; CDS840233F , Lot Number 21DBP203 ; CDS840233G , Lot Number 21JBZ341 ; CDS840233G , Lot Number 21LBH656 ; CDS840233G , Lot Number 21LBH658 ; CDS840261AA, Lot Number 21FBQ526 ; CDS840261AA, Lot Number 21HBF183 ; CDS840261AA, Lot Number 21LBU767 ; CDS840261AA, Lot Number 19EBA002 ; CDS840261AA, Lot Number 19EBO269 ; CDS840261AA, Lot Number 19EBS093 ; CDS840261AA, Lot Number 19SBD590 ; CDS840261AA, Lot Number 19IBH166 ; CDS840261AA, Lot Number 19LBW464 ; CDS840261AA, Lot Number 19LBY062 ; CDS840261AA, Lot Number 20DBA246 ; CDS840261AA, Lot Number 20GBU560 ; CDS840261AA, Lot Number 20JBD178 ; CDS840261AA, Lot Number 21ABG464 ; CDS840261AA, Lot Number 21CBI435 ; CDS840261AA, Lot Number 21DBJ725 ; CDS840295F , Lot Number 19ABW903 ; CDS840295F , Lot Number 19BBP926 ; CDS840295F , Lot Number 19CBV566 ; CDS840295F , Lot Number 19EBR803 ; CDS840343K , Lot Number 21HBM974 ; CDS840343K , Lot Number 21JBH421 ; CDS840343K , Lot Number 21LBP632 ; CDS840343K , Lot Number 19BBI846 ; CDS840343K , Lot Number 19CBN448 ; CDS840343K , Lot Number 22DBK084 ; CDS840343K , Lot Number 19EBM546 ; CDS840343K , Lot Number 19GBI361 ; CDS840343K , Lot Number 19HBH487 ; CDS840343K , Lot Number 22JBB144 ; CDS840343K , Lot Number 22JBG405 ; CDS840343K , Lot Number 22JBR833 ; CDS840343K , Lot Number 19IBH989 ; CDS840343K , Lot Number 23BBP209 ; CDS840343K , Lot Number 23BBP340 ; CDS840343K , Lot Number 23CBV969 ; CDS840343K , Lot Number 19LBU159 ; CDS840343K , Lot Number 20ABZ962 ; CDS840343K , Lot Number 20BBT763 ; CDS840343K , Lot Number 23GBB119 ; CDS840343K , Lot Number 23GBW141 ; CDS840343K , Lot Number 20EBO730 ; CDS840343K , Lot Number 23IBL698 ; CDS840343K , Lot Number 23JBE434 ; CDS840343K , Lot Number 23KBP732 ; CDS840343K , Lot Number 20IBC382 ; CDS840343K , Lot Number 20IBQ897 ; CDS840343K , Lot Number 20JBR280 ; CDS840343K , Lot Number 24CBA919 ; CDS840343K , Lot Number 21ABI745 ; CDS840343K , Lot Number 21BBJ321 ; CDS840343K , Lot Number 21DBF273 ; CDS840343K , Lot Number 21EBF601 ; CDS840354N , Lot Number 19EBC693 ; CDS840354N , Lot Number 19GBC532 ; CDS840354O , Lot Number 19HBN051 ; CDS840354O , Lot Number 19KBB920 ; CDS840354O , Lot Number 19LBQ515 ; CDS840354P , Lot Number 21FBP633 ; CDS840354P , Lot Number 21GBV725 ; CDS840354P , Lot Number 21IBA006 ; CDS840354P , Lot Number 21IBA007 ; CDS840354P , Lot Number 21KBO456 ; CDS840354P , Lot Number 22ABY131 ; CDS840354P , Lot Number 20CBG521 ; CDS840354P , Lot Number 20DBP928 ; CDS840354P , Lot Number 20GBP278 ; CDS840354P , Lot Number 20HBU135 ; CDS840354P , Lot Number 20LBA007 ; CDS840354P , Lot Number 21DBE093 ; CDS840354P , Lot Number 22FMG222 ; CDS840354P , Lot Number 22FMG225 ; CDS840354Q , Lot Number 22HMG262 ; CDS840354Q , Lot Number 22IMB557 ; CDS840354Q , Lot Number 22LMI106 ; CDS840354Q , Lot Number 23CME942 ; CDS840354Q , Lot Number 23CMF221 ; CDS840354Q , Lot Number 23EMK143 ; CDS840368L , Lot Number 19ABJ865 ; CDS840368L , Lot Number 19DBI529 ; CDS840368L , Lot Number 19RBA316 ; CDS840368L , Lot Number 19HBH361 ; CDS840368L , Lot Number 19JBJ645 ; CDS840368L , Lot Number 19KBB870 ; CDS840368L , Lot Number 19KBO528 ; CDS840368L , Lot Number 20BBB586 ; CDS840368L , Lot Number 20CBF697 ; CDS840368L , Lot Number 20EBC255 ; CDS840368L , Lot Number 20FBR638 ; CDS840368L , Lot Number 20HBG896 ; CDS840368L , Lot Number 20IBN708 ; CDS840368L , Lot Number 20KBK052 ; CDS840379L , Lot Number 19ABX922 ; CDS840453C , Lot Number 19BBF379 ; CDS840453C , Lot Number 19CBR365 ; CDS840453C , Lot Number 19DBD836 ; CDS840453C , Lot Number 19DBY533 ; CDS840453C , Lot Number 19FBX606 ; CDS840453C , Lot Number 19TBB345 ; CDS840453C , Lot Number 19IBZ494 ; CDS840453C , Lot Number 19LBY088 ; CDS840453C , Lot Number 20BBW909 ; CDS840453C , Lot Number 20HBF103 ; CDS840453C , Lot Number 20HBT185 ; CDS840453C , Lot Number 20JBD511 ; CDS840453C , Lot Number 21ABH722 ; CDS840459N , Lot Number 19ABQ283 ; CDS840459N , Lot Number 19BBI845 ; CDS840459N , Lot Number 19CBG430 ; CDS840459N , Lot Number 19DBY010 ; CDS840459N , Lot Number 19FBR828 ; CDS840459N , Lot Number 19TBC625 ; CDS840459N , Lot Number 19IBE967 ; CDS840459N , Lot Number 19JBU899 ; CDS840459N , Lot Number 19KBB801 ; CDS840468B , Lot Number 21HMC746 ; CDS840468B , Lot Number 21HMF545 ; CDS840468B , Lot Number 21IMA279 ; CDS840468B , Lot Number 21IMB709 ; CDS840468B , Lot Number 21JMF577 ; CDS840468B , Lot Number 21KMD461 ; CDS840468B , Lot Number 22BMB111 ; CDS840468B , Lot Number 22DMD084 ; CDS840468B , Lot Number 22KMD493 ; CDS840468B , Lot Number 22LMA066 ; CDS840468B , Lot Number 22LME436 ; CDS840468B , Lot Number 22LME834 ; CDS840468B , Lot Number 23EME854 ; CDS840468B , Lot Number 23IMA273 ; CDS840468B , Lot Number 23JMI185 ; CDS840468B , Lot Number 19CKB125 ; CDS840468B , Lot Number 19EKD809 ; CDS840468B , Lot Number 19GKA710 ; CDS840468B , Lot Number 19HKD258 ; CDS840468B , Lot Number 19JKA541 ; CDS840468B , Lot Number 20AKC093 ; CDS840468B , Lot Number 20GKB425 ; CDS840468B , Lot Number 20LKA068 ; CDS840468B , Lot Number 21AKA582 ; CDS840468B , Lot Number 21CKA462 ; CDS840472N , Lot Number 19ABZ610 ; CDS840472N , Lot Number 19CBS257 ; CDS840472N , Lot Number 19DBA546 ; CDS840472N , Lot Number 19DBN639 ; CDS840472N , Lot Number 19EBT399 ; CDS840472N , Lot Number 19FBJ752 ; CDS840472N , Lot Number 19GBZ853 ; CDS840472N , Lot Number 19IBH312 ; CDS840472N , Lot Number 19JBC420 ; CDS840490J , Lot Number 19BBO475 ; CDS840490J , Lot Number 19EBN057 ; CDS840490J , Lot Number

Distribution pattern

Worldwide distribution.

device · product 40 of 81

Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 6) 18GX6" FEMORAL ART LINE KIT, Pack Number ART960A; 7) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 8) BIOPSY TRAY, Pack Number BT1015; 9) BIOPSY TRAY, Pack Number BT1060; 10) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number BT1095; 11) BIOPSY KIT, Pack Number BT450A ; 12) CHEST TUBE INSERTION TRAY , Pack Number CHT1020; 13) CHEST TUBE INSERTION KIT, Pack Number CHT1465; 14) CHEST TUBE INSERTION TRAY , Pack Number CHT2040; 15) CHEST TUBE INSERTION TRAY , Pack Number CHT2040H ; 16) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 17) CHEST TUBE INSERTION TRAY , Pack Number CHT701 ; 18) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 19) CIRCUMCISION TRAY, Pack Number CIT6260; 20) CIRCUMCISION TRAY, Pack Number CIT6325; 21) CIRCUMCISION TRAY , Pack Number CIT6575A ; 22) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 23) CHEST TUBE INSERTION TRAY , Pack Number CVI2105; 24) CHEST TUBE INSERTION TRAY , Pack Number CVI2105H ; 25) EXTREMITY PACK, Pack Number CVI4680; 26) CVC INSERTION PACK, Pack Number CVI4720; 27) VENOUS ACCESS TRAY, Pack Number CVI4830A; 28) VENOUS ACCESS TRAY, Pack Number CVI4830B; 29) MVHS CVC LUMEN TRAY, Pack Number CVI4920; 30) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960A; 31) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 32) CATHETER ON/OFF KIT, Pack Number DT5490B; 33) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 34) BIOPSY KIT, Pack Number DYNDA1466A; 35) CUP KIT, Pack Number DYNDA1506; 36) DERMATOLOGY KIT, Pack Number DYNDA1567D; 37) TDC REMOVAL, Pack Number DYNDA1633A; 38) PAN MP TRACHEOSTOMY, Pack Number DYNDA1635; 39) PERM CATH, Pack Number DYNDA1732A; 40) CATH REMOVAL, Pack Number DYNDA1733B; 41) CATH REMOVAL, Pack Number DYNDA1814; 42) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 43) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 44) PORT TUNNEL CATH REMOVAL TRAY, Pack Number DYNDA2033A; 45) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 46) PULL D/C PACK, Pack Number DYNDA2080; 47) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 48) PAIN TRAY, Pack Number DYNDA2416; 49) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 50) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 51) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 52) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523A; 53) GENERAL UTILITY, Pack Number DYNDA2524; 54) SHUNT TRAY, Pack Number DYNDA2725; 55) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 56) PICU LINE TRAY, Pack Number DYNDC1960A; 57) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 58) PORT ACCESS KIT, Pack Number DYNDC2945; 59) PRE POST DIALYSIS, Pack Number DYNDC3274; 60) BMA BX TRAY, Pack Number DYNDH1050A; 61) BONE MARROW TRAY - NO NEEDLE, Pack Number DYNDH1059; 62) BIOPSY PACK SM, Pack Number DYNDH1093; 63) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 64) ARTHROGRAM TRAY, Pack Number DYNDH1113; 65) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 66) BIOPSY TRAY, Pack Number DYNDH1129; 67) ARTHROGRAM TRAY, Pack Number DYNDH1134; 68) BIOPSY PACK, Pack Number DYNDH1137A; 69) BIOPSY TRAY, Pack Number DYNDH1137C; 70) ARTHROGRAM PACK, Pack Number DYNDH1148; 71) ULTRASOUND TRAY, Pack Number DYNDH1204; 72) IR PICC TRAY, Pack Number DYNDH1223; 73) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 74) BIOPSY TRAY-LF, Pack Number DYNDH1229; 75) ARTHROGRAM TRAY, Pack Number DYNDH1243; 76) BIOPSY PACK, Pack Number DYNDH1248; 77) BONE MARROW BIOPSY TRAY, Pack Number DYNDH1251; 78) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 79) BIOPSY TRAY, Pack Number DYNDH1269; 80) BIOPSY TRAY, Pack Number DYNDH1273; 81) FLUORO PROCEDURE TRAY, Pack Number DYNDH1276; 82) BONE MARROW

Z-3020-2024
Recall number
Z-3020-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

81239, Lot Number 24DDA646; 81239, Lot Number 24BDA159; 81239, Lot Number 24ADA118; 81239, Lot Number 23LDB385; 81239, Lot Number 23FDB922; 81239, Lot Number 23FDB435; 81239, Lot Number 23CDC570; 81239, Lot Number 23BDA790; 81239, Lot Number 23ADA161; 81239, Lot Number 22LDA211; 81239, Lot Number 22KDA441; 81239, Lot Number 22HDA985; 81239, Lot Number 22GDB017; 81239, Lot Number 22FDA642; 81239, Lot Number 22BDB971; 81239, Lot Number 22BDB067; 81239, Lot Number 22BDA725; 81239, Lot Number 21LDA117; 81239, Lot Number 21KDB172; 81239, Lot Number 21HDA966; 81239, Lot Number 21GDD227; 81239, Lot Number 21DDC268; 81239, Lot Number 21DDA425; 81239, Lot Number 21CDB386; 81239, Lot Number 21BDB285; 81239, Lot Number 21ADA073; 946279 , Lot Number 21BKA450 ; ART1165, Lot Number 2022081890; ART1165, Lot Number 2022111890; ART1165, Lot Number 2023071190; ART1165, Lot Number 2023083190; ART1165, Lot Number 2023092290; ART1165, Lot Number 2023110990; ART1165, Lot Number 2023122990; ART1165, Lot Number 2024031290; ART1210, Lot Number 2023080190; ART240B, Lot Number 2023112290; ART240B, Lot Number 2024031590; ART960A, Lot Number 2023082890; ART960A, Lot Number 2023092790; ART960A, Lot Number 2023112990; ART960A, Lot Number 2023122190; ART960A, Lot Number 2024020190; ART970A, Lot Number 2023082890; ART970A, Lot Number 2023120790; BT1015, Lot Number 2019031190; BT1015, Lot Number 2021030190; BT1015, Lot Number 2022030490; BT1060, Lot Number 2020010790; BT1060 , Lot Number 21HBS949 ; BT1060 , Lot Number 21IBP676 ; BT1060 , Lot Number 21KBR236 ; BT1060 , Lot Number 21LBF894 ; BT1060 , Lot Number 22ABX733 ; BT1060 , Lot Number 22FBK864 ; BT1060 , Lot Number 22KBP269 ; BT1060 , Lot Number 23EBD654 ; BT1060 , Lot Number 23FBP748 ; BT1060 , Lot Number 23KBC222 ; BT1060 , Lot Number 23LBL371 ; BT1060 , Lot Number 21ABF385 ; BT1060 , Lot Number 21ABT342 ; BT1060 , Lot Number 21BBO441 ; BT1060 , Lot Number 21CBV637 ; BT1095, Lot Number 2020020790; BT1095, Lot Number 2020022690; BT450A , Lot Number 21JBG947 ; CHT1020, Lot Number 21JBN310 ; CHT1465, Lot Number 21HBR240 ; CHT1465, Lot Number 21KBC516 ; CHT1465, Lot Number 22BBH387 ; CHT1465, Lot Number 22BBR031 ; CHT1465, Lot Number 22FBU118 ; CHT1465, Lot Number 21DBD915 ; CHT1465, Lot Number 22IMD540 ; CHT1465, Lot Number 23CMC009 ; CHT1465, Lot Number 23EMA144 ; CHT1465, Lot Number 23FMA800 ; CHT1465, Lot Number 23FME610 ; CHT1465, Lot Number 23FMF447 ; CHT1465, Lot Number 23HMB406 ; CHT1465, Lot Number 23HMD786 ; CHT1465, Lot Number 23IME835 ; CHT1465, Lot Number 23JMJ875 ; CHT1465, Lot Number 23KMI144 ; CHT2040, Lot Number 22HBM306 ; CHT2040, Lot Number 23HBC212 ; CHT2040, Lot Number 23HBS289 ; CHT2040, Lot Number 23IBE762 ; CHT2040H , Lot Number 22HBM306 ; CHT2040H , Lot Number 23HBC212 ; CHT2040H , Lot Number 23HBS289 ; CHT2040H , Lot Number 23IBE762 ; CHT560, Lot Number 2019073090; CHT560, Lot Number 2020080390; CHT701 , Lot Number 21FBO591 ; CHT701 , Lot Number 21JBW717 ; CHT701 , Lot Number 21VBA867 ; CHT701 , Lot Number 21KBN653 ; CHT701 , Lot Number 22CBO057 ; CHT701 , Lot Number 22EBG420 ; CHT701 , Lot Number 22JBM927 ; CHT701 , Lot Number 22JBT787 ; CHT701 , Lot Number 23GBR820 ; CHT701 , Lot Number 23JBK474 ; CHT701 , Lot Number 21CBO702 ; CHT701 , Lot Number 21FBD963 ; CHT705, Lot Number 2020012990; CIT6260, Lot Number 2021101590; CIT6325, Lot Number 2023120790; CIT6575A , Lot Number 22KBS245 ; CIT6575A , Lot Number 22LBL593 ; CIT6785A, Lot Number 2021072790; CIT6785A, Lot Number 2021111690; CIT6785A, Lot Number 2023102490; CVI2105, Lot Number 21JBM278 ; CVI2105, Lot Number 21KBS086 ; CVI2105, Lot Number 21BBH919 ; CVI2105, Lot Number 21CBI631 ; CVI2105, Lot Number 21CBI632 ; CVI2105, Lot Number 21DBA095 ; CVI2105, Lot Number 22FMD732 ; CVI2105, Lot Number 22HMD248 ; CVI2105, Lot Number 23EMI806 ; CVI2105, Lot Number 23FMA158 ; CVI2105, Lot Number 23FMH191 ; CVI2105, Lot Number 23HMD107 ; CVI2105, Lot Number 23JMD860 ; CVI2105, Lot Number 23KMF012 ; CVI2105, Lot Number 23LMC909 ; CVI2105H , Lot Number 21JBM278 ; CVI2105H , Lot Number 21KBS086 ; CVI2105H , Lot Number 22FMD732 ; CVI2105H , Lot Number 22HMD248 ; CVI2105H , Lot Number 23EMI806 ; CVI2105H , Lot Number 23FMA158 ; CVI2105H , Lot Number 23FMH191 ; CVI2105H , Lot Number 23HMD107 ; CVI2105H , Lot Number 23JMD860 ; CVI2105H , Lot Number 23KMF012 ; CVI2105H , Lot Number 23LMC909 ; CVI2105H , Lot Number 21BBH919 ; CVI2105H , Lot Number 21CBI631 ; CVI2105H , Lot Number 21CBI632 ; CVI2105H , Lot Number 21DBA095 ; CVI4680, Lot Number 2020120950; CVI4720, Lot Number 2021050650; CVI4830A, Lot Number 2022053150; CVI4830A, Lot Number 2022112180; CVI4830B, Lot Number 2023022780; CVI4920, Lot Number 2022111480; CVI4920, Lot Number 2023020680; CVI4960A, Lot Number 2023121190; CVI4970, Lot Number 2023052280; CVI4970, Lot Number 2023082880; CVI4970, Lot Number 2023112080; DT5490B, Lot Number 2023072890; DT5490B, Lot Number 2023102490; DT5490B, Lot Number 2023112290; DYNDA1432A, Lot Number 2018112890; DYNDA1432A, Lot Number 2019052990; DYNDA1432A, Lot Number 2019070390; DYNDA1432A, Lot Number 2019091390; DYNDA1466A, Lot Number 2019121850; DYNDA1466A, Lot Number 2021090101; DYNDA1466A, Lot Number 2022110490; DYNDA1466A, Lot Number 2023072890; DYNDA1466A, Lot Number 2023100390; DYNDA1466A, Lot Number 2023120790; DYNDA1506, Lot Number 2023050890; DYNDA1567D, Lot Number 2019051590; DYNDA1567D, Lot Number 2019052490; DYNDA1567D, Lot Number 2019080790; DYNDA1567D, Lot Number 2019112290; DYNDA1567D, Lot Number 2020010890; DYNDA1633A, Lot Number 2018071350; DYNDA1633A, Lot Number 2018122150; DYNDA1633A, Lot Number 2019052850; DYNDA1633A, Lot Number 2019061050; DYNDA1633A, Lot Number 2019081350; DYNDA1633A, Lot Number 2019102950; DYNDA1633A, Lot Number 2020031250; DYNDA1633A, Lot Number 2020121150; DYNDA1633A, Lot Number 2021030450; DYNDA1633A, Lot Number 2021060350; DYNDA1633A, Lot Number 2022033150; DYNDA1635, Lot Number 2020022190; DYNDA1732A, Lot Number 2019042490; DYNDA1732A, Lot Number 2019091990; DYNDA1732A, Lot Number 2020010990; DYNDA1732A, Lot Number 2020031090; DYNDA1733B, Lot Number 2018032750; DYNDA1733B, Lot Number 2018052450; DYNDA1733B, Lot Number 2019032250; DYNDA1733B, Lot Number 2019040250; DYNDA1733B, Lot Number 2019062750; DYNDA1733B, Lot Number 2019080950; DYNDA1733B, Lot Number 2019111350; DYNDA1733B, Lot Number 2019123050; DYNDA1733B, Lot Number 2020090101; DYNDA1733B, Lot Number 2020111601; DYNDA1733B, Lot Number 2020122201; DYNDA1733B, Lot Number 2021042301; DYNDA1733B, Lot Number 2021052801; DYNDA1733B, Lot Number 2021062801; DYNDA1733B, Lot Number 2021112401; DYNDA1733B, Lot Number 2022032901; DYNDA1814, Lot Number 2020071650; DYNDA1894, Lot Number 2020020790; DYNDA1977A, Lot Number 2019042490; DYNDA1977A, Lot Number 2019090590; DYNDA2033A, Lot Number 2018050750; DYNDA2063, Lot Number 2019012550; DYNDA2063, Lot Number 2020082650; DYNDA2063, Lot Number 2020092950; DYNDA2063, Lot Number 2020101950; DYNDA2063, Lot Number 2020103050; DYNDA2063, Lot Number 2021071450; DYNDA2063, Lot Number 2021091350; DYNDA2063, Lot Number 2022022550; DYNDA2080, Lot Number 2018082790; DYNDA2080, Lot Number 2019030690; DYNDA2080, Lot Number 2019102590; DYNDA2213A, Lot Number 2019061080; DYNDA2213A, Lot Number 2019070180; DYNDA2213A, Lot Number 2019101480; DYNDA2213A, Lot Number 2020012780; DYNDA2416, Lot Number 2020081790; DYNDA2416, Lot Number 2021011590; DYNDA2416, Lot Number 2021071590; DYNDA2416, Lot Number 2021100490; DYNDA2416, Lot Number 2022012490; DYNDA2416, Lot Number 2022061490; DYNDA2416, Lot Number 2022093090; DYNDA2416, Lot Number 2023021090; DYNDA2416, Lot Number 2023063090; DYNDA2416, Lot Number 2023112190; DYNDA2495, Lot Number 2019061750; DYNDA2495, Lot Number 2019061950; DYNDA2495, Lot Number 2019070150; DYNDA2495, Lot Number 2020052950; DYNDA2495, Lot Number 2020062650; DYNDA2495, Lot Number 2020082150; DYNDA2495, Lot Number 2021030850; DYNDA2495, Lot Number 2021052850; DYNDA2495, Lot Number 2021073050; DYNDA2495, Lot Number 2021092850; DYNDA2495, Lot Number 2021113050; DYNDA2495, Lot Number 2021122950; DYNDA2495, Lot Number 2022052550; DYNDA2495, Lot Number 2022120790; DYNDA2495, Lot Number 2022122890; DYNDA2495, Lot Number 2023042490; DYNDA2495, Lot Number 2023042790; DYNDA2495, Lot Number 2023082890; DYNDA2495, Lot Number 2023100390; DYNDA2495, Lot Number 2023111690; DYNDA2495, Lot Number 2023120790; DYNDA2495, Lot Number RS21113050; DYNDA2497, Lot Number 2019071250; DYNDA2497, Lot Number 2019122350; DYNDA2497, Lot Number 2020010250; DYNDA2497, Lot Number 2020072750; DYNDA2497, Lot Number 2020082450; DYNDA2497, Lot Number 2021092050; DYNDA2497, Lot Number 2022041150; DYNDA2497, Lot Number 2022120790; DYNDA2497, Lot Number 2023120790; DYNDA2523, Lot Number 2019111290; DYNDA2523, Lot Number 2022051390; DYNDA2523, Lot Number 2022062890; DYNDA2523, Lot Number 2023031790; DYNDA2523A, Lot Number 2023032490; DYNDA2524, Lot Number 2019073090; DYNDA2524, Lot Number 2019091890; DYNDA2524, Lot Number 2019120390; DYNDA2524, Lot Number 2020030290; DYNDA2725, Lot Number 2020121090; DYNDA2725, Lot Number 2021101490; DYNDA2725, Lot Number 2022030490; DYNDA2725, Lot Number 2022040690; DYNDA2725, Lot Number 2022062790; DYNDA2725, Lot Number 2022083190; DYNDA2725, Lot Number 2023050890; DYNDA2725, Lot Number 2023071190; DYNDA2725, Lot Number 2023091290; DYNDA2725, Lot Number 2023122690; DYNDA2906, Lot Number 2022020950; DYNDC1960A, Lot Number 2018031350; DYNDC1960A, Lot Number 2018031650; DYNDC1960A, Lot Number 2019042350; DYNDC1960A, Lot Number 2023031590; DYNDC2859A, Lot Number 2021032990; DYNDC2859A, Lot Number 2021052590; DYNDC2859A, Lot Number 2022042190; DYNDC2859A, Lot Number 2022060290; DYNDC2945, Lot Number 2021040590; DYNDC2945, Lot Number 2022042190; DYNDC2945, Lot Number 2022060290; DYNDC2945, Lot Number 2022080190; DYNDC3274, Lot Number 2023020890; DYNDH1050A, Lot Number 2019061790; DYNDH1050A, Lot Number 2019081490; DYNDH1050A, Lot Number 2019112790; DYNDH1050A, Lot Number 2020022190; DYNDH1059, Lot Number 2020082150; DYNDH1093, Lot Number 2018071690; DYNDH1093, Lot Number 2018072090; DYNDH1093, Lot Number 2018121890; DYNDH1093, Lot Number 2018092090; DYNDH1093, Lot Number 2019061790; DYNDH1093, Lot Number 2019081490; DYNDH1093, Lot Number 2019092690; DYNDH1093, Lot Number 2019120290; DYNDH1093, Lot Number 2020030590; DYNDH1108, Lot Number 2019112890; DYNDH1113, Lot Number 2019062550; DYNDH1113, Lot Number 2020031250; DYNDH1113, Lot Number 2021012150; DYNDH1113, Lot Number 2021051050; DYNDH1113, Lot Number 2021060350; DYNDH1113, Lot Number 2021081050; DYNDH1113, Lot Number 2021111650; DYNDH1115, Lot Number 2019121090; DYNDH1115, Lot Number 2020012790; DYNDH1129, Lot Number 2018110550; DYNDH1129, Lot Number 2019123050; DYNDH1129, Lot Number 2020012050; DYNDH1134, Lot Number 2018051050; DYNDH1134, Lot Number 2018061550; DYNDH1134, Lot Number 2018061850; DYNDH1134, Lot Number 2018062850; DYNDH1134, Lot Number 2019050650; DYNDH1134, Lot Number 2019072950; DYNDH1134, Lot Number 2019123050; DYNDH1134, Lot Number 2020081050; DYNDH1134, Lot Number 2020102250; DYNDH1134, Lot Number 2021010750; DYNDH1134, Lot Number 2021042350; DYNDH1134, Lot Number 2021072650; DYNDH1134, Lot Number 2021100650; DYNDH1134, Lot Number 2022011850; DYNDH1137A, Lot Number 2019021290; DYNDH1137A, Lot Number 2019020190; DYNDH1137C, Lot Number 2020012990; DYNDH1137C, Lot Number 2021040590; DYNDH1137C, Lot Number 2022042190; DYNDH1137C, Lot Number 2022080190; DYNDH1137C, Lot Number 2023010390; DYNDH1148, Lot Number 2018072590; DYNDH1148, Lot Number 2018080190; DYNDH1204, Lot Number 2018040350; DYNDH1204, Lot Number 2018040250; DYNDH1204, Lot Number 2018081750; DYNDH1223, Lot Number 2019040250; DYNDH1227B, Lot Number 2019072990; DYNDH1227B, Lot Number 2019082390; DYNDH1227B, Lot Number 2019120290; DYNDH1227B, Lot Number 2020012490; DYNDH1227B, Lot Number 2020022690; DYNDH1229, Lot Number 2021120150; DYNDH1243, Lot Number 2019081490; DYNDH1243, Lot Number 2019092490; DYNDH1243, Lot Number 2019100890; DYNDH1243, Lot Number 2019111490; DYNDH1243, Lot Number 2019112890; DYNDH1243, Lot Number 2020010790; DYNDH1243, Lot Number 2020021090; DYNDH1248, Lot Number 2018062250; DYNDH1248, Lot Number 2018121750; DYNDH1248, Lot Number 2019011550; DYNDH1251, Lot Number 2020021490; DYNDH1257, Lot Number 2018082950; DYNDH1257, Lot Number 2018111250; DYNDH1257, Lot Number 2019012550; DYNDH1257, Lot Number 2019050650; DYNDH1257, Lot Number 2019071950; DYNDH1257, Lot Number 2020102250; DYNDH1257, Lot Number 2022032350; DYNDH1269, Lot Number 2018082950; DYNDH1269, Lot Number 2018110550; DYNDH1269, Lot Number 2019031950; DYNDH1269, Lot Number 2019041550; DYNDH1269, Lot Number 2019051650; DYNDH1269, Lot Number 2019070250; DYNDH1269, Lot Number 2019101150; DYNDH1269, Lot Number 2019112650; DYNDH1269, Lot Number 2020031950; DYNDH1269, Lot Number 2020091801; DYNDH1269, Lot Number 2021011501; DYNDH1269, Lot Number 2021031901; DYNDH1269, Lot Number 2021051001; DYNDH1269, Lot Number 2021083080; DYNDH1269, Lot Number 2021101880; DYNDH1269, Lot Number 2021112980; DYNDH1269, Lot Number 2022040480; DYNDH1269, Lot Number 2022062780; DYNDH1273, Lot Number 2018092790; DYNDH1273, Lot Number 2018101790; DYNDH1273, Lot Number 2019020890; DYNDH1273, Lot Number 2019032190; DYNDH1273, Lot Number 2019083090; DYNDH1273, Lot Number 2019102190; DYNDH1276, Lot Number 2018120390; DYNDH1276, Lot Number 2020030490; DYNDH1287A, Lot Number 2022050550; DYNDH1297, Lot Number 2018071150; DYNDH1297, Lot Number 2018082950; DYNDH1297, Lot Number 2018101750; DYNDH1297, Lot Number 2019070150; DYNDH1297, Lot Number 2019071950; DYNDH1297, Lot Number 2019102850; DYNDH1297, Lot Number 2019112650; DYNDH1297, Lot Number 2020100650; DYNDH1297, Lot Number 2021010750; DYNDH1297, Lot Number 2021030450; DYNDH1297, Lot Number 2021051450; DYNDH1297, Lot Number 2021101450; DYNDH1297, Lot Number 2022022450; DYNDH1297, Lot Number 2022040850; DYNDH1300, Lot Number 2021011150; DYNDH1300, Lot Number 2022022450; DYNDH1304A, Lot Number 2020030290; DYNDH1314A, Lot Number 2020041550; DYNDH1314A, Lot Number 2020082601; DYNDH1314A, Lot Number 2020111001; DYNDH1314A, Lot Number 2021020101; DYNDH1314A, Lot Number 2021040801; DYNDH1314A, Lot Number 2021052601; DYNDH1314A, Lot Number 2021081801; DYNDH1314A, Lot Number 2021100101; DYNDH1314A, Lot Number 2021120301; DYNDH1314A, Lot Number 2023072601; DYNDH1314A, Lot Number 2023080301; DYNDH1314A, Lot Number 2023082801; DYNDH1314A, Lot Number 2023092901; DYNDH1314A, Lot Number 2023110201; DYNDH1314A, Lot Number 2023120601; DYNDH1318, Lot Number 2018092150; DYNDH1319, Lot Number 2019032250; DYNDH1319, Lot Number 2019051650; DYNDH1319, Lot Number 2020100850; DYNDH1319, Lot Number 2020111250; DYNDH1319, Lot Number 2021050650; DYNDH1319, Lot Number 2021071950; DYNDH1319, Lot Number 2021102850; DYNDH1321, Lot Number 2019011590; DYNDH1321, Lot Number 2019060390; DYNDH1321, Lot Number 2019120690; DYNDH1322, Lot Number 2018122190; DYNDH1322, Lot Number 2019032590; DYNDH1322, Lot Number 2019121690; DYNDH1322, Lot Number 2020030390; DYNDH1324, Lot Number 2018092150; DYNDH1324, Lot Number 2018101950; DYNDH1324, Lot Number 2019071850; DYNDH1324, Lot Number 2019110150; DYNDH1324, Lot Number 2020032750; DYNDH1324A, Lot Number 2020051350; DYNDH1324A, Lot Number 2020081250; DYNDH1324A, Lot Number 2021032550; DYNDH1324A, Lot Number 2021070850; DYNDH1324A, Lot Number 2021111650; DYNDH1324B, Lot Number 2022060650; DYNDH1332A, Lot Number 2020030450; DYNDH1332A, Lot Number 2020110550; DYNDH1332A, Lot Number 2021012550; DYNDH1332A, Lot Number 2022110490; DYNDH1332A, Lot Number 2022120990; DYNDH1340, Lot Number 2019112690; DYNDH1349, Lot Number 2018092690; DYNDH1349, Lot Number 2018121390; DYNDH1349, Lot Number 2019021490; DYNDH1349, Lot Number 2020022090; DYNDH1350, Lot Number 2019091290; DYNDH1350, Lot Number 2019121090; DYNDH1355A, Lot Number 2020013050; DYNDH1355A, Lot Number 2021051901; DYNDH1359, Lot Number 2018111290; DYNDH1359, Lot Number 2023112190; DYNDH1406, Lot Number 2019032550; DYNDH1406, Lot Number 2019052950; DYNDH1406, Lot Number 2020072450; DYNDH1406, Lot Number 2021012801; DYNDH1406, Lot Number 2021033001; DYNDH1406, Lot Number 2021051901; DYNDH1406, Lot Number 2021090101; DYNDH1406, Lot Number 2021100101; DYNDH1406, Lot Number 2023033190; DYNDH1406, Lot Number 2023080290; DYNDH1426, Lot Number 2019060450; DYNDH1426, Lot Number 2021092850; DYNDH1430A, Lot Number 2023010380; DYNDH1484, Lot Number 2020011590; DYNDH1484, Lot Number 2020021090; DYNDH1484, Lot Number 2020061790; DYNDH1484, Lot Number 2020100190; DYNDH1496, Lot Number 2020100190; DYNDH1498, Lot Number 2020042390; DYNDH1498, Lot Number 2020080390; DYNDH1507, Lot Number 2020051450; DYNDH1518A, Lot Number 2022070250; DYNDH1531, Lot Number 2020062990; DYNDH1531, Lot Number 2021011590; DYNDH1531, Lot Number 2021021290; DYNDH1531, Lot Number 2021030190; DYNDH1531, Lot Number 2021042090; DYNDH1531, Lot Number 2021052590; DYNDH1531, Lot Number 2021063090; DYNDH1531, Lot Number 2021110390; DYNDH1531, Lot Number 2022022890; DYNDH1531, Lot Number 2022071890; DYNDH1531, Lot Number 2023050290; DYNDH1531, Lot Number 2023061290; DYNDH1531, Lot Number 2023103090; DYNDH1531, Lot Number 2023122690; DYNDH1540A, Lot Number 2021012750; DYNDH1540A, Lot Number 2022062890; DYNDH1540A, Lot Number 2022071890; DYNDH1540A, Lot Number 2023072890; DYNDH1556A, Lot Number 2021071950; DYNDH1556B, Lot Number 2021122950; DYNDH1559, Lot Number 2020091850; DYNDH1570, Lot Number 2020092350; DYNDH1570, Lot Number 2021062250; DYNDH1570, Lot Number 2022042350; DYNDH1570, Lot Number 2022062890; DYNDH1570, Lot Number 2022082290; DYNDH1570, Lot Number 2023051290; DYNDH1570, Lot Number 2023071490; DYNDH1570, Lot Number 2023121390; DYNDH1574, Lot Number 2020102150; DYNDH1574, Lot Number 2021031250; DYNDH1574, Lot Number 2021061150; DYNDH1574, Lot Number 2021062850; DYNDH1574, Lot Number 2021081850; DYNDH1574, Lot Number 2021102850; DYNDH1574, Lot Number 2021121450; DYNDH1574, Lot Number 2022060150; DYNDH1580, Lot Number 2021050650; DYNDH1580, Lot Number 2021092050; DYNDH1580, Lot Number 2022041150; DYNDH1585, Lot Number 2021011150; DYNDH1585, Lot Number 2021042750; DYNDH1585, Lot Number 2021061050; DYNDH1585, Lot Number 2022070250; DYNDH1585, Lot Number 2022071450; DYNDH1588, Lot Number 2021060450; DYNDH1588, Lot Number 2021071950; DYNDH1588, Lot Number 2021100750; DYNDH1588, Lot Number 2022030750; DYNDH1588, Lot Number 2022062450; DYNDH1588, Lot Number 2022072550; DYNDH1588, Lot Number 2022080350; DYNDH1588, Lot Number 2022102480; DYNDH1588, Lot Number 2022112180; DYNDH1588, Lot Number 2022121980; DYNDH1588, Lot Number 2023040380; DYNDH1638, Lot Number 2022032350; DYNDH1652, Lot Number 2021072850; DYNDH1689, Lot Number 2022020350; DYNDH1689, Lot Number 2022030350; DYNDH1689, Lot Number 2022040850; DYNDH1689, Lot Number 2022042750; DYNDH1699, Lot Number 2022070250; DYNDH1699, Lot Number 2022072750; DYNDH1699, Lot Number 2022122290; DYNDH1699, Lot Number 2023051290; DYNDH1699, Lot Number 2023072890; DYNDH1699, Lot Number 2023100290; DYNDH1699, Lot Number 2023120190; DYNDH1706, Lot Number 2022033150; DYNDH1713, Lot Number 2022022450; DYNDH1713, Lot Number 2022050650; DYNDH1713, Lot Number 2022062350; DYNDH1726, Lot Number 2022040250; DYNDH1726, Lot Number 2022060650; DYNDH1726, Lot Number 2022070850; DYNDH1727, Lot Number 2022040850; DYNDH1727, Lot Number 2022071750; DYNDH1755, Lot Number 2022072750; DYNDH1841, Lot Number 2023031590; DYNDH1841A, Lot Number 2023092190; DYNDH1841A, Lot Number 2023112190; DYNDL1096, Lot Number 2019032990; DYNDL1096, Lot Number 2019052090; DYNDL1096, Lot Number 2019062690; DYNDL1096, Lot Number 2019081390; DYNDL1096, Lot Number 2019120990; DYNDL1096, Lot Number 2020020790; DYNDL1159B, Lot Number 2019011480; DYNDL1159B, Lot Number 2019041580; DYNDL1159B, Lot Number 2019052080; DYNDL1159B, Lot Number 2019081280; DYNDL1159B, Lot Number 2019091680; DYNDL1159B, Lot Number 2020040680; DYNDL1187A, Lot Number 2018061390; DYNDL1187A, Lot Number 2018072090; DYNDL1187A, Lot Number 2018081390; DYNDL1187A, Lot Number 2019011890; DYNDL1187A, Lot Number 2019083090; DYNDL1250C, Lot Number 2018082490; DYNDL1250C, Lot Number 2019051690; DYNDL1250C, Lot Number 2019061490; DYNDL1250C, Lot Number 2019090490; DYNDL1250C, Lot Number 2019093090; DYNDL1250C, Lot Number 2020022190; DYNDL1422A, Lot Number 2019072690; DYNDL1422A, Lot Number 2019111990; DYNDL1422A, Lot Number 2019120990; DYNDL1422A, Lot Number 2020022090; DYNDL1422A, Lot Number 2020031790; DYNDL1443B, Lot Number 2018050950; DYNDL1461, Lot Number 2018082950; DYNDL1461, Lot Number 2018092050; DYNDL1461, Lot Number 2018111550; DYNDL1461, Lot Number 2019020750; DYNDL1461, Lot Number 2019040150; DYNDL1461, Lot Number 2019051750; DYNDL1461, Lot Number 2019070250; DYNDL1461, Lot Number 2019071950; DYNDL1461, Lot Number 2019091850; DYNDL1461, Lot Number 2019101150; DYNDL1461, Lot Number 2019111250; DYNDL1461, Lot Number 2019121250; DYNDL1461, Lot Number 2020071650; DYNDL1461, Lot Number 2020081350; DYNDL1461, Lot Number 2020092150; DYNDL1461, Lot Number 2020102650; DYNDL1461, Lot Number 2021051750; DYNDL1461, Lot Number 2021071450; DYNDL1461, Lot Number 2021102750; DYNDL1461, Lot Number 2022013150; DYNDL1462B, Lot Number 2018031950; DYNDL1462B, Lot Number 2018032150; DYNDL1462B, Lot Number 2018060550; DYNDL1462B, Lot Number 2018100250; DYNDL1462B, Lot Number 2019022750; DYNDL1462B, Lot Number 2019041050; DYNDL1462B, Lot Number 2019080850; DYNDL1462B, Lot Number 2019100850; DYNDL1462B, Lot Number 2019102950; DYNDL1462B, Lot Number 2020041650; DYNDL1462B, Lot Number 2020092850; DYNDL1462B, Lot Number 2021031850; DYNDL1462B, Lot Number 2021050650; DYNDL1462B, Lot Number 2021062450; DYNDL1462B, Lot Number 2021100650; DYNDL1462B, Lot Number 2022021050; DYNDL1569A, Lot Number 2018061990; DYNDL1569A, Lot Number 2018062790; DYNDL1569A, Lot Number 2018072390; DYNDL1569A, Lot Number 2018081590; DYNDL1569A, Lot Number 2019032090; DYNDL1569A, Lot Number 2019051390; DYNDL1569A, Lot Number 2019081690; DYNDL1569A, Lot Number 2019092690; DYNDL1569A, Lot Number 2019112290; DYNDL1569A, Lot Number 2020022690; DYNDL1571B, Lot Number 2019030690; DYNDL1571B, Lot Number 2019100290; DYNDL1571B, Lot Number 2020010790; DYNDL1722, Lot Number 2019060390; DYNDL1739, Lot Number 2018111290; DYNDL1739, Lot Number 2019020890; DYNDL1739, Lot Number 2019032790; DYNDL1739, Lot Number 2019062190; DYNDL1757, Lot Number 2019071790; DYNDL1757, Lot Number 2020010790; DYNDL1772, Lot Number 2018122190; DYNDL1772, Lot Number 2019041690; DYNDL1772, Lot Number 2019051690; DYNDL1772, Lot Number 2019082290; DYNDL1772, Lot Number 2019091990; DYNDL1772, Lot Number 2019102590; DYNDL1772, Lot Number 2020031190; DYNDL1774A, Lot Number 2019010390; DYNDL1774A, Lot Number 2019012990; DYNDL1774A, Lot Number 2019061790; DYNDL1774A, Lot Number 2019081290; DYNDL1774A, Lot Number 2019102290; DYNDL1774A, Lot Number 2019120690; DYNDL1774A, Lot Number 2020021490; DYNDL1887, Lot Number 2019042390; DYNDL1887, Lot Number 2019061290; DYNDL1887, Lot Number 2019090490; DYNDL1898, Lot Number 2019021250; DYNDL1898, Lot Number 2019032050; DYNDL1898, Lot Number 2019040250; DYNDL2952, Lot Number 2020052890; DYNDL2952, Lot Number 2020092490; DYNDL2952, Lot Number 2021072790; DYNDL2952, Lot Number 2021081290; DYNDL2952, Lot Number 2021090690; DYNDL2952, Lot Number 2021101490; DYNDL2952, Lot Number 2022041490; DYNDL2952, Lot Number 2022052390; DYNDL2952, Lot Number 2022071890; DYNDL2952, Lot Number 2022120790; DYNDL2952, Lot Number 2023050890; DYNDL2952, Lot Number 2023062090; DYNDL2952, Lot Number 2023102490; DYNDS1064B, Lot Number 2019042980; DYNDS1064B, Lot Number 2019082680; DYNDS1064B, Lot Number 2019093080; DYNDS1064B, Lot Number 2020022480; DYNDV1588F, Lot Number 2019102590; DYNJ04162, Lot Number 23BBE128 ; DYNJ04162, Lot Number 23CBQ393 ; DYNJ04162, Lot Number 23CBV205 ; DYNJ04162, Lot Number 23EBE121 ; DYNJ04162, Lot Number 23FBF865 ; DYNJ04162, Lot Number 23GBR313 ; DYNJ04162, Lot Number 23HBX269 ; DYNJ04162, Lot Number 23HBZ391 ; DYNJ04162, Lot Number 23IBP884 ; DYNJ04162, Lot Number 23KBM597 ; DYNJ04162H , Lot Number 23BBE128 ; DYNJ04162H , Lot Number 23CBQ393 ; DYNJ04162H , Lot Number 23CBV205 ; DYNJ04162H , Lot Number 23EBE121 ; DYNJ04162H , Lot Number 23FBF865 ; DYNJ04162H , Lot Number 23GBR313 ; DYNJ04162H , Lot Number 23HBX269 ; DYNJ04162H , Lot Number 23HBZ391 ; DYNJ04162H , Lot Number 23IBP884 ; DYNJ04162H , Lot Number 23KBM597 ; DYNJ05162, Lot Number 2019111350; DYNJ05162, Lot Number 2020110550; DYNJ05162, Lot Number 2021012750; DYNJ05162, Lot Number 2021042750; DYNJ36762A , Lot Number 21FLA929 ; DYNJ36762A , Lot Number 21ILA164 ; DYNJ36762A , Lot Number 21ILA986 ; DYNJ36762A , Lot Number 21JLA315 ; DYNJ36762A , Lot Number 21KLA005 ; DYNJ36762A , Lot Number 21KLA162 ; DYNJ36762A , Lot Number 21KLA629 ; DYNJ36762A , Lot Number 22FLA472 ; DYNJ36762A , Lot Number 22ILA678 ; DYNJ36762A , Lot Number 22KLA066 ; DYNJ36762A , Lot Number 23CLA135 ; DYNJ36762A , Lot Number 23DLA436 ; DYNJ36762A , Lot Number 23ELA127 ; DYNJ36762A , Lot Number 23FLA622 ; DYNJ36762A , Lot Number 23GLA417 ; DYNJ36762A , Lot Number 23KLA169 ; DYNJ36762A , Lot Number 23KLB162 ; DYNJ36762AH, Lot Number 21FLA929 ; DYNJ36762AH, Lot Number 21ILA164 ; DYNJ36762AH, Lot Number 21ILA986 ; DYNJ36762AH, Lot Number 21JLA315 ; DYNJ36762AH, Lot Number 21KLA005 ; DYNJ36762AH, Lot Number 21KLA162 ; DYNJ36762AH, Lot Number 21KLA629 ; DYNJ36762AH, Lot Number 22FLA472 ; DYNJ36762AH, Lot Number 22ILA678 ; DYNJ36762AH, Lot Number 22KLA066 ; DYNJ36762AH, Lot Number 23CLA135 ; DYNJ36762AH, Lot Number 23DLA436 ; DYNJ36762AH, Lot Number 23ELA127 ; DYNJ36762AH, Lot Number 23FLA622 ; DYNJ36762AH, Lot Number 23GLA417 ; DYNJ36762AH, Lot Number 23KLA169 ; DYNJ36762AH, Lot Number 23KLB162 ; DYNJRA0659, Lot Number 2019050690; DYNJRA0659, Lot Number 2019071590; DYNJTS0018A, Lot Number 2020041450; DYNJTS0018A, Lot Number 2020102150; DYNJTS0018A, Lot Number 2021051750; DYNJTS0036, Lot Number 2018091350; DYNJTS0036, Lot Number 2018112650; DYNJTS0036, Lot Number 2019010750; DYNJTS0036, Lot Number 2019042350; DYNJTS0036, Lot Number 2019051050; DYNJTS0214, Lot Number 2020092950; DYNJTS0214, Lot Number 2021031250; DYNJTS0214, Lot Number 2021072650; DYNJTS0214, Lot Number 2022062890; DYNJTS04035, Lot Number 2019120250; DYNJTS04035, Lot Number 2019120250; DYNJTS04035, Lot Number 2020082550; DYNJTS04035, Lot Number 2020091850; DYNJTS04035, Lot Number 2020102350; DYNJTS04035, Lot Number 2020120950; DYNJTS04035, Lot Number 2021012250; DYNJTS0404A, Lot Number 2019112750; DYNJTS0404A, Lot Number 2020062550; DYNJTS0404A, Lot Number 2020072450; DYNJTS0404A, Lot Number 2020080450; DYNJTS0404A, Lot Number 2020081750; DYNJTS0404A, Lot Number 2021062550; DYNJTS0404A, Lot Number 2021072050; DYNJTS0404A, Lot Number 2022011350; DYNJTS0404A, Lot Number 2022041150; DYNJTS0512, Lot Number 2021041150; DYNJTS0512, Lot Number 2021051550; DYNJTS0512, Lot Number 2021061150; DYNJTS0512, Lot Number 2021072950; DYNJTS0512, Lot Number 2021082050; DYNJTS0512, Lot Number 2021092650; DYNJTS0512, Lot Number 2021120450; DYNJTS0512, Lot Number 2022011050; DYNJTS0512, Lot Number 2022012850; DYNJTS0512, Lot Number 2022021350; DYNJTS0512, Lot Number 2022022850; DYNJTS0512, Lot Number 2022032350; DYNJTS0514, Lot Number 2020100850; DYNJTS0514, Lot Number 2021051750; DYNJTS0514, Lot Number 2021070850; DYNJTS0514, Lot Number 2021100650; DYNJTS0514, Lot Number 2022060350; DYNJTS07025, Lot Number 2020052950; DYNJTS07035, Lot Number 2021062850; DYNJTS07035, Lot Number 2021070850; DYNJTS07035, Lot Number 2021072650; DYNJTS07035, Lot Number 2021080450; DYNJTS07035, Lot Number 2021082050; DYNJTS07035, Lot Number 2021082350; DYNJTS07035, Lot Number 2022020450; DYNJTS2343T, Lot Number 2020090150; DYNJTS2343T, Lot Number 2020101650; DYNJTS2343T, Lot Number 2021012750; DYNJTS2343T, Lot Number 2021030450; DYNJTS2343T, Lot Number 2021061550; DYNJTS2343T, Lot Number 2021072650; DYNJTS2343T, Lot Number 2022011250; DYNJTS2343T, Lot Number 2022060250; DYNJTS4301, Lot Number 2020102250; DYNJTS4301, Lot Number 2020102250; DYNJTS4301, Lot Number 2021060750; DYNJTS4301, Lot Number 2021072950; DYNJTS4302, Lot Number 2021121450; DYNJTS4306, Lot Number 2020110550; DYNJTS4306, Lot Number 2021032550; DYNJTS4306, Lot Number 2021061150; DYNJTS8100, Lot Number 2020111950; EBSI1241, Lot Number 2023032490; ECVC8050, Lot Number 2023031590; GSC065DB, Lot Number 2019020890; GSC065DB, Lot Number 2019040490; GSC065DB, Lot Number 2019050890; GSC065DB, Lot Number 2019072490; GSC065DB, Lot Number 2019092490; GSC065DB, Lot Number 2019110590; GSC065DB, Lot Number 2020021190; KABX01B, Lot Number 2019022050; M101346B, Lot Number 2019080790; M101346B, Lot Number 2019092490; M101346B, Lot Number 2019111990; M101347B, Lot Number 2019110590; M101347B, Lot Number 2019120290; MNS10875A, Lot Number 2023080190; MNS11020A, Lot Number 2019082290; MNS11020A, Lot Number 2021040590; MNS11020A, Lot Number 2022022890; MNS11590, Lot Number 2019061790; MNS11590, Lot Number 2019090590; MNS12670A, Lot Number 2021040590; MNS12670A, Lot Number 2022030490; MNS12700, Lot Number 2022083190; MNS3345A, Lot Number 23KBG041; MNS3345A, Lot Number 23GBI070; MNS3345A, Lot Number 23EBU454; MNS3345A, Lot Number 23DBE660; MNS3345A, Lot Number 22KBU038; MNS3355, Lot Number 2019120290; MNS4815, Lot Number 2022082290; MNS4815, Lot Number 2023111690; MNS5155, Lot Number 23KBL485; MNS5155, Lot Number 23JBB317; MNS5155H, Lot Number 23KBL485; MNS5155H, Lot Number 23JBB317; MNS5460, Lot Number 2019091890; MNS5460, Lot Number 21GBS365 ; MNS5460, Lot Number 21IBI307 ; MNS5460, Lot Number 21IBI353 ; MNS5460, Lot Number 21JBZ924 ; MNS5460, Lot Number 21KBN192 ; MNS5460, Lot Number 21LBS510 ; MNS5460, Lot Number 22FBM311 ; MNS5460, Lot Number 22HBQ067 ; MNS5460, Lot Number 22IBV082 ; MNS5460, Lot Number 22JBU758 ; MNS5460, Lot Number 22KBJ182 ; MNS5460, Lot Number 23GBJ025 ; MNS5460, Lot Number 21BBC358 ; MNS5460, Lot Number 21BBC387 ; MNS5460, Lot Number 21EBB603 ; MNS5575, Lot Number 2019083090; MNS5575, Lot Number 2019112290; MNS6465, Lot Number 2018071990; MNS6465, Lot Number 2022082290; MNS6496, Lot Number 2018092790; MNS6496, Lot Number 2019111390; MNS6496, Lot Number 2020121090; MNS6496, Lot Number 2022051390; MNS6496, Lot Number 2023112290; MNS8340, Lot Number 21IBI310 ; MNS8340, Lot Number 21JBT679 ; MNS8340, Lot Number 21LBJ253 ; MNS8340, Lot Number 22ABX842 ; MNS8340, Lot Number 22EBB220 ; MNS8340, Lot Number 22FBA468 ; MNS8340, Lot Number 22JBW906 ; MNS8340, Lot Number 23BBP316 ; MNS8340, Lot Number 23FBA607 ; MNS8340, Lot Number 23HBS668 ; MNS8340, Lot Number 21CBY113 ; MNS8340, Lot Number 21EBF560 ; MNS9580, Lot Number 2020121090; MNS9580, Lot Number 2023091290; MNS9580, Lot Number 2023112190; MNS9860, Lot Number 21JBI244 ; MNS9860, Lot Number 21JBX202 ; MNS9860, Lot Number 21LBL877 ; MNS9860, Lot Number 22FBN120 ; MNS9860, Lot Number 22HBO387 ; MNS9860, Lot Number 22HBY603 ; MNS9860, Lot Number 22JBB962 ; MNS9860, Lot Number 22KBA809 ; P151659, Lot Number 2018100890; P151659, Lot Number 2019060790; P151659, Lot Number 2019073190; P151659, Lot Number 2020030290; P241108, Lot Number 2018052150; P241108, Lot Number 2018062250; P241108, Lot Number 2018080150; P241108, Lot Number 2018112750; P241108, Lot Number 2019020750; P241108, Lot Number 2019032250; P241108, Lot Number 2019050350; P241108, Lot Number 2019060450; P241108, Lot Number 2019090550; P241108, Lot Number 2019120950; P241108, Lot Number 2020041450; P241108, Lot Number 2020092950; P241108, Lot Number 2021032550; P241108, Lot Number 2021060750; P241108, Lot Number 2022052550; P268481, Lot Number 2019071250; P268481, Lot Number 2020062550; P42

Distribution pattern

Worldwide distribution.

device · product 41 of 81

Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR PACK , Pack Number DYNJ17507B ; 6) STARTER PACK CMH-LF , Pack Number DYNJ41737C ; 7) DELIVERY PACK ME-LF , Pack Number DYNJ45589B ; 8) STERILE STARTER SET PACK, Pack Number DYNJ47814; 9) IVF PACK, Pack Number DYNJ63783; 10) VI PACK , Pack Number DYNJ64811; 11) VI PACK , Pack Number DYNJ64871; 12) IR CENTRAL KIT, Pack Number DYNJ68285; 13) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0011; 14) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0012; 15) LACERATION TRAY, Pack Number SUT20955; 16) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 17) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225; 18) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225H ; 19) UMBILICAL TRAY W/3.5&5FR CATH , Pack Number UVT1250H

Z-3021-2024
Recall number
Z-3021-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CVI4915, Lot Number 2022103180; DYNDC1318D, Lot Number 2019012590; DYNJ0101308C , Lot Number 19BKC672 ; DYNJ04047C , Lot Number 21FBN548 ; DYNJ04047C , Lot Number 21GBL027 ; DYNJ04047C , Lot Number 21IBX365 ; DYNJ04047C , Lot Number 22ABM052 ; DYNJ04047C , Lot Number 19ABD460 ; DYNJ04047C , Lot Number 22CBP491 ; DYNJ04047C , Lot Number 22OBI898 ; DYNJ04047C , Lot Number 19FBD994 ; DYNJ04047C , Lot Number 22IBH860 ; DYNJ04047C , Lot Number 22IBJ054 ; DYNJ04047C , Lot Number 22LBR925 ; DYNJ04047C , Lot Number 19VBB656 ; DYNJ04047C , Lot Number 23ABS681 ; DYNJ04047C , Lot Number 19KBC727 ; DYNJ04047C , Lot Number 19KBF911 ; DYNJ04047C , Lot Number 20DBF312 ; DYNJ04047C , Lot Number 20JBC775 ; DYNJ17507B , Lot Number 19JDB044 ; DYNJ17507B , Lot Number 20EDA752 ; DYNJ17507B , Lot Number 20FDB395 ; DYNJ17507B , Lot Number 20IDB921 ; DYNJ17507B , Lot Number 20JDA956 ; DYNJ17507B , Lot Number 20LDB169 ; DYNJ17507B , Lot Number 21GDA031 ; DYNJ17507B , Lot Number 21HDB179 ; DYNJ17507B , Lot Number 21JDC732 ; DYNJ17507B , Lot Number 23ADA442 ; DYNJ41737C , Lot Number 21FBK597 ; DYNJ41737C , Lot Number 21GBM874 ; DYNJ41737C , Lot Number 21IBD142 ; DYNJ41737C , Lot Number 21JBB598 ; DYNJ41737C , Lot Number 21JBB602 ; DYNJ41737C , Lot Number 21WBA194 ; DYNJ41737C , Lot Number 21LBP147 ; DYNJ41737C , Lot Number 22ABE433 ; DYNJ41737C , Lot Number 19ABJ657 ; DYNJ41737C , Lot Number 19CBB947 ; DYNJ41737C , Lot Number 22OBI031 ; DYNJ41737C , Lot Number 19CBO914 ; DYNJ41737C , Lot Number 19DBC698 ; DYNJ41737C , Lot Number 19DBO702 ; DYNJ41737C , Lot Number 22FBJ538 ; DYNJ41737C , Lot Number 19RBC166 ; DYNJ41737C , Lot Number 22HBV259 ; DYNJ41737C , Lot Number 19SBB262 ; DYNJ41737C , Lot Number 22JBK898 ; DYNJ41737C , Lot Number 19IBB771 ; DYNJ41737C , Lot Number 19IBE072 ; DYNJ41737C , Lot Number 19JBE636 ; DYNJ41737C , Lot Number 19LBT637 ; DYNJ41737C , Lot Number 20CBC820 ; DYNJ41737C , Lot Number 23GBF976 ; DYNJ41737C , Lot Number 23HBE132 ; DYNJ41737C , Lot Number 20EBD652 ; DYNJ41737C , Lot Number 20FBN024 ; DYNJ41737C , Lot Number 23JBK069 ; DYNJ41737C , Lot Number 23LBI143 ; DYNJ41737C , Lot Number 20JBE583 ; DYNJ41737C , Lot Number 21BBS926 ; DYNJ41737C , Lot Number 21CBX913 ; DYNJ45589B , Lot Number 18LBQ229 ; DYNJ45589B , Lot Number 19BBI698 ; DYNJ45589B , Lot Number 19EBB616 ; DYNJ47814, Lot Number 19BBC131 ; DYNJ47814, Lot Number 19DBQ381 ; DYNJ47814, Lot Number 19GBA816 ; DYNJ47814, Lot Number 19IBK685 ; DYNJ47814, Lot Number 19KBJ696 ; DYNJ47814, Lot Number 19LBU531 ; DYNJ47814, Lot Number 20CBY831 ; DYNJ47814, Lot Number 20FBI187 ; DYNJ63783, Lot Number 21JBB671 ; DYNJ63783, Lot Number 21KBJ500 ; DYNJ63783, Lot Number 22BBF553 ; DYNJ63783, Lot Number 22OBI679 ; DYNJ63783, Lot Number 22EBE312 ; DYNJ63783, Lot Number 22HBM741 ; DYNJ63783, Lot Number 22IBH464 ; DYNJ63783, Lot Number 19HBB067 ; DYNJ63783, Lot Number 23DBJ842 ; DYNJ63783, Lot Number 20ABM496 ; DYNJ63783, Lot Number 23FBH844 ; DYNJ63783, Lot Number 20CBL632 ; DYNJ63783, Lot Number 23GBH242 ; DYNJ63783, Lot Number 20EBH703 ; DYNJ63783, Lot Number 23IBF782 ; DYNJ63783, Lot Number 20HBD244 ; DYNJ63783, Lot Number 20JBM648 ; DYNJ63783, Lot Number 20JBW602 ; DYNJ63783, Lot Number 20LBP393 ; DYNJ63783, Lot Number 21DBP053 ; DYNJ64811, Lot Number 19KBO216 ; DYNJ64871, Lot Number 21IBR317 ; DYNJ64871, Lot Number 21KBR802 ; DYNJ64871, Lot Number 21KBR840 ; DYNJ64871, Lot Number 22BBZ525 ; DYNJ64871, Lot Number 22EBN632 ; DYNJ64871, Lot Number 22GBV097 ; DYNJ64871, Lot Number 22LBK474 ; DYNJ64871, Lot Number 23ABB889 ; DYNJ64871, Lot Number 19KBP348 ; DYNJ64871, Lot Number 20ABR888 ; DYNJ64871, Lot Number 23EBJ477 ; DYNJ64871, Lot Number 20BBK386 ; DYNJ64871, Lot Number 23FBO926 ; DYNJ64871, Lot Number 23GBQ643 ; DYNJ64871, Lot Number 23HBM974 ; DYNJ64871, Lot Number 23KBF276 ; DYNJ64871, Lot Number 20HBN235 ; DYNJ64871, Lot Number 20KBG137 ; DYNJ64871, Lot Number 20XBF536 ; DYNJ64871, Lot Number 21BBL845 ; DYNJ68285, Lot Number 21AME264 ; PICC0011, Lot Number 2022030150; PICC0011, Lot Number 2022061090; PICC0012, Lot Number 2022022450; SUT20955, Lot Number 2019012590; UVT1100A, Lot Number 2022103180; UVT1225, Lot Number 23BBJ869 ; UVT1225, Lot Number 23DBN509 ; UVT1225H , Lot Number 23BBJ869 ; UVT1225H , Lot Number 23DBN509 ; UVT1250H , Lot Number 23IBE795 ; UVT1250H , Lot Number 23KBE411

Distribution pattern

Worldwide distribution.

device · product 42 of 81

Medline Convenience kits labeled as: SCS-LF, DYNJ902314D

Z-3022-2024
Recall number
Z-3022-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ902314D, Lot Number 20FDA446 ; DYNJ902314D, Lot Number 20GDA480 ; DYNJ902314D, Lot Number 20IDA880 ; DYNJ902314D, Lot Number 20JDA187 ; DYNJ902314D, Lot Number 21CDA064 ; DYNJ902314D, Lot Number 21EDA709 ; DYNJ902314D, Lot Number 21EDA908 ; DYNJ902314D, Lot Number 21FDA451 ; DYNJ902314D, Lot Number 21FDB959 ; DYNJ902314D, Lot Number 21HDA759 ; DYNJ902314D, Lot Number 21IDC401 ; DYNJ902314D, Lot Number 21KDC395 ; DYNJ902314D, Lot Number 22CDA599 ; DYNJ902314D, Lot Number 22EDB585 ; DYNJ902314D, Lot Number 22IDA541 ; DYNJ902314D, Lot Number 22KDB745 ; DYNJ902314D, Lot Number 23BDA383 ; DYNJ902314D, Lot Number 23DDB444 ; DYNJ902314D, Lot Number 23EDA371

Distribution pattern

Worldwide distribution.

device · product 43 of 81

Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) LACERATION TRAY , Pack Number DYNDL1062B ; 7) LACERATION TRAY , Pack Number DYNDL1073; 8) LACERATION TRAY , Pack Number DYNDL1076; 9) LACERATION TRAY , Pack Number DYNDL1090A ; 10) ER LACERATION TRAY, Pack Number DYNDL1096; 11) LACERATION TRAY , Pack Number DYNDL1151C ; 12) LACERATION TRAY , Pack Number DYNDL1152A ; 13) LACERATION TRAY , Pack Number DYNDL1152AH; 14) LACERATION TRAY , Pack Number DYNDL1159B ; 15) LACERATION TRAY , Pack Number DYNDL1163; 16) LACERATION TRAY , Pack Number DYNDL1163H ; 17) LACERATION TRAY , Pack Number DYNDL1171; 18) CUSTOM LACERATION TRAY, Pack Number DYNDL1177C ; 19) E. R. LACERATION TRAY , Pack Number DYNDL1187A ; 20) LACERATION TRAY , Pack Number DYNDL1208B ; 21) LACERATION TRAY, Pack Number DYNDL1223A; 22) LACERATION TRAY , Pack Number DYNDL1250C ; 23) LACERATION TRAY , Pack Number DYNDL1257A ; 24) LACERATION TRAY , Pack Number DYNDL1263A ; 25) TRAY,LACERATION , Pack Number DYNDL1271B ; 26) LACERATION TRAY , Pack Number DYNDL1284; 27) LACERATION TRAY , Pack Number DYNDL1285; 28) LACERATION TRAY , Pack Number DYNDL1366A ; 29) LACERATION TRAY , Pack Number DYNDL1368; 30) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377A ; 31) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377AH; 32) LACERATION TRAY , Pack Number DYNDL1399; 33) LACERATION TRAY , Pack Number DYNDL1403; 34) LACERATION TRAY , Pack Number DYNDL1406A ; 35) TRAY,LACERATION , Pack Number DYNDL1455; 36) LACERATION TRAY , Pack Number DYNDL1457; 37) TRAY LACERATION , Pack Number DYNDL1465; 38) LACERATION TRAY , Pack Number DYNDL1496; 39) LACERATION TRAY , Pack Number DYNDL1496H ; 40) TRAY,LACERATION , Pack Number DYNDL1510; 41) TRAY,LACERATION, Pack Number DYNDL1542; 42) TRAY,LACERATION , Pack Number DYNDL1542; 43) TRAY ER LACERATION, Pack Number DYNDL1569A ; 44) TRAY SM ER LACERATION , Pack Number DYNDL1573; 45) LACERATION TRAY , Pack Number DYNDL1575A ; 46) LACERATION TRAY , Pack Number DYNDL1628A ; 47) LACERATION TRAY , Pack Number DYNDL1634; 48) LACERATION PACK , Pack Number DYNDL1637A ; 49) LACERATION TRAY , Pack Number DYNDL1678; 50) LACERATION TRAY , Pack Number DYNDL1679B ; 51) LACERATION TRAY , Pack Number DYNDL1690; 52) ER LACERATION TRAY, Pack Number DYNDL1693; 53) LACERATION TRAY , Pack Number DYNDL1705; 54) LACERATION TRAY, Pack Number DYNDL1705H ; 55) SUTURE LACERATION KIT , Pack Number DYNDL1707A ; 56) LACERATION TRAY , Pack Number DYNDL1714; 57) LACERATION KIT, Pack Number DYNDL1717; 58) NMG LACERATION TRAY , Pack Number DYNDL1722; 59) LACERATION TRAY , Pack Number DYNDL1728; 60) LACERATION TRAY , Pack Number DYNDL1729; 61) LACERATION TRAY , Pack Number DYNDL1739; 62) LACERATION TRAY , Pack Number DYNDL1740; 63) LACERATION TRAY , Pack Number DYNDL1757; 64) LACERATION TRAY , Pack Number DYNDL1758; 65) LACERATION TRAY, Pack Number DYNDL1758H ; 66) LACERATION TRAY HIGH GRADE, Pack Number DYNDL1762; 67) LACERATION TRAY , Pack Number DYNDL1768; 68) LACERATION TRAY , Pack Number DYNDL1770B ; 69) LACERATION TRAY , Pack Number DYNDL1772; 70) LACERATION TRAY , Pack Number DYNDL1774A ; 71) LACERATION TRAY W/SAFETY NDLS , Pack Number DYNDL1783; 72) LACERATION TRAY , Pack Number DYNDL1790; 73) LACERATION TRAY , Pack Number DYNDL1838; 74) LACERATION TRAY , Pack Number DYNDL1870; 75) LACERATION TRAY , Pack Number DYNDL1870H ; 76) LACERATION TRAY , Pack Number DYNDL1872; 77) LACERATION TRAY W/ UNDERPAD , Pack Number DYNDL1878; 78) LACERATION TRAY , Pack Number DYNDL1887; 79) LACERATION TRAY , Pack Number DYNDL1888; 80) LACERATION TRAY , Pack Number DYNDL1892; 81) LACERATION TRAY , Pack Number DYNDL1920; 82) LACERATION TRAY W/ ADSON FCP, Pack Number DYNDL1923A ; 83) LACERATION TRAY

Z-3023-2024
Recall number
Z-3023-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS930092U , Lot Number 19ABG536 ; CDS930092U , Lot Number 19BBK958 ; CDS930092U , Lot Number 19CBW838 ; CDS930092U , Lot Number 19EBW656 ; CDS930092U , Lot Number 19GBQ822 ; CDS930092U , Lot Number 19IBD005 ; CDS930092U , Lot Number 19VBC035 ; CDS930092U , Lot Number 20ABF408 ; CDS930092U , Lot Number 20BBN475 ; CDS930092U , Lot Number 20CBW941 ; CDS930092U , Lot Number 20EBD309 ; CDS930092U , Lot Number 20FBC457 ; CDS930092U , Lot Number 20GBQ330 ; CDS930092U , Lot Number 20HBQ731 ; CDS930092U , Lot Number 20IBM524 ; CDS930092U , Lot Number 20LBC008 ; DYNDA1822, Lot Number 21JBI823 ; DYNDA2865, Lot Number 22BBT129; DYNDH1495A , Lot Number 21JBQ007 ; DYNDL1050, Lot Number 21JBR511 ; DYNDL1062B , Lot Number 22JMC782 ; DYNDL1062B , Lot Number 23CMD085 ; DYNDL1062B , Lot Number 23FMB278 ; DYNDL1062B , Lot Number 23HMD252 ; DYNDL1062B , Lot Number 23IMB553 ; DYNDL1062B , Lot Number 23KMG005 ; DYNDL1073, Lot Number 21JBJ599 ; DYNDL1076, Lot Number 21JBT719 ; DYNDL1090A , Lot Number 21JBF345 ; DYNDL1096, Lot Number 19CBD823 ; DYNDL1096, Lot Number 22HBZ149 ; DYNDL1096, Lot Number 22IBB980 ; DYNDL1096, Lot Number 20DBU111 ; DYNDL1096, Lot Number 20FBP250 ; DYNDL1096, Lot Number 20JBD367 ; DYNDL1096, Lot Number 20WBC515 ; DYNDL1096, Lot Number 21DBA107 ; DYNDL1151C , Lot Number 21JBF370 ; DYNDL1152A , Lot Number 21JBP002 ; DYNDL1152AH, Lot Number 21JBP002 ; DYNDL1159B , Lot Number 21IBL692 ; DYNDL1159B , Lot Number 21KBS039 ; DYNDL1159B , Lot Number 21KBY562 ; DYNDL1159B , Lot Number 23ABJ966 ; DYNDL1159B , Lot Number 20FBI861 ; DYNDL1159B , Lot Number 20FBU760 ; DYNDL1159B , Lot Number 20HBL711 ; DYNDL1159B , Lot Number 20JBN968 ; DYNDL1159B , Lot Number 21ABH267 ; DYNDL1159B , Lot Number 21ABP087 ; DYNDL1159B , Lot Number 21DBD507 ; DYNDL1159B , Lot Number 21DBX946 ; DYNDL1163, Lot Number 21JBL241 ; DYNDL1163H , Lot Number 21JBL241 ; DYNDL1171, Lot Number 21JBG957 ; DYNDL1171, Lot Number 21JBR534 ; DYNDL1177C , Lot Number 23KBF572 ; DYNDL1187A , Lot Number 21HBG848 ; DYNDL1187A , Lot Number 21IBU306 ; 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DYNJ60586, Lot Number 23IBF075 ; DYNJ60586, Lot Number 23JBO369 ; DYNJ60586, Lot Number 20GBS185 ; DYNJ60586, Lot Number 23KBQ986 ; DYNJ60586, Lot Number 20IBD558 ; DYNJ60586, Lot Number 20JBD786 ; DYNJ60586, Lot Number 20JBK289 ; DYNJ60586, Lot Number 21ABW403 ; DYNJ60586, Lot Number 21ABX243 ; DYNJ60586, Lot Number 21CBU925 ; DYNJ67990, Lot Number 21IME909 ; DYNJ67990, Lot Number 21KMC498 ; DYNJ67990, Lot Number 21KMI066 ; DYNJ67990, Lot Number 21LMD561 ; DYNJ67990, Lot Number 22AMC023 ; DYNJ67990, Lot Number 22AME196 ; DYNJ67990, Lot Number 22DMH679 ; DYNJ67990, Lot Number 22EMG464 ; DYNJ67990, Lot Number 22FMF131 ; DYNJ67990, Lot Number 22HMB880 ; DYNJ68223, Lot Number 21GBA785 ; DYNJ68223, Lot Number 21GBQ366 ; DYNJ68223, Lot Number 21HBB432 ; DYNJ68223, Lot Number 21IBW511 ; DYNJ68223, Lot Number 21BBB437 ; DYNJ68223, Lot Number 21DBE487 ; DYNJ68223, Lot Number 21EBE127 ; DYNJ68808, Lot Number 21GBN159 ; DYNJ68808, Lot Number 21IBU081 ; DYNJ68808, Lot Number 21LBT965 ; DYNJ68808, Lot Number 22NBG365 ; DYNJ68808, Lot Number 21DBC976 ; DYNJ80201, Lot Number 22ABY939 ; DYNJ80201A , Lot Number 22HBN480 ; DYNJ80201A , Lot Number 22IBE619 ; DYNJ80201A , Lot Number 22JBK565 ; DYNJ80201A , Lot Number 23BBM778 ; DYNJ80201A , Lot Number 23CBH775 ; DYNJ80201A , Lot Number 23DBJ566 ; DYNJ80201A , Lot Number 23EBK372 ; DYNJ80201A , Lot Number 23GBL847 ; DYNJ80201A , Lot Number 23IBD093 ; DYNJ80201A , Lot Number 23IBU061 ; DYNJ80201A , Lot Number 23JBS712 ; DYNJ80201A , Lot Number 23LBO062 ; DYNJ80201A , Lot Number 24ABU885 ; DYNJ83054A , Lot Number 22LME582 ; DYNJ83054A , Lot Number 23EMH715 ; DYNJ83054A , Lot Number 23KMA828 ; P392929, Lot Number 23JBH231 ; P948416, Lot Number 21GBF901 ; P948416, Lot Number 21IBI785 ; P948416, Lot Number 21LBF893 ; P948416, Lot Number 20BBZ489 ; P948416, Lot Number 20EBD522 ; P948416, Lot Number 20GBS490 ; P948416, Lot Number 20IBB944 ; P948416, Lot Number 20IBP670 ; P948416, Lot Number 21ABK378 ; P948416, Lot Number 22DMA834 ; P948416, Lot Number 22FMA125 ; P948416, Lot Number 22JME305 ; P948416, Lot Number 23DME672 ; P948416, Lot Number 23EMJ769 ; P948416, Lot Number 23HME168 ; P948416, Lot Number 23IMB508 ; SD-4060, Lot Number 21JBT597 ; SD-4060, Lot Number 23JBH120 ; SD-4060H , Lot Number 21JBT597 ; SD-4060H , Lot Number 23JBH120 ; STL121L, Lot Number 19BBR062 ; STL121L, Lot Number 19EBT327 ; STL121L, Lot Number 19HBN562 ; STL121L, Lot Number 19HBZ519 ; STL121L, Lot Number 19KBC986

Distribution pattern

Worldwide distribution.

device · product 44 of 81

Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY , Pack Number DYNDC3282; 7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ; 8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ; 9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ; 10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ; 11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ; 12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ; 13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ; 14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ; 15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ; 16) PK-SETUP PACK , Pack Number DYNJ43804A ; 17) SKIN LESION PACK, Pack Number DYNJ44258G ; 18) SETUP PACK, Pack Number DYNJ46187D ; 19) PK-SET UP -LF , Pack Number DYNJ53220B ; 20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ; 21) SKIN SCRUB PACK , Pack Number DYNJ68561; 22) DMEK PREP PACK, Pack Number DYNJ81659A ; 23) SET UP PACK , Pack Number DYNJ84247; 24) BASIC SET UP PACK-LF, Pack Number DYNJ85036; 25) SET UP CDS-ASC, Pack Number DYNJ900073C; 26) GENERAL SET UP, Pack Number DYNJ906282C; 27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A; 28) SET UP, Pack Number DYNJ909403 ; 29) PREP TRAY , Pack Number DYNJRA1280A; 30) PREP TRAY , Pack Number DYNJRA1424 ; 31) NERVE BLOCK/W , Pack Number DYNJRA1424H; 32) PREP TRAY, Pack Number DYNJRA1498B; 33) PREP TRAY , Pack Number DYNJRA1583C; 34) PREP TRAY , Pack Number DYNJRA1760 ; 35) PREP TRAY , Pack Number DYNJRA1774 ; 36) PREP TRAY , Pack Number DYNJRA1783 ; 37) PREP TRAY , Pack Number DYNJRA1946A; 38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ; 39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A

Z-3024-2024
Recall number
Z-3024-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDA1540, Lot Number 23JBV995; DYNDA1540, Lot Number 23GBA155; DYNDA1540, Lot Number 23EBB508; DYNDA1540, Lot Number 22LBK096; DYNDA1540, Lot Number 22JBQ748; DYNDA1540, Lot Number 22HBC421; DYNDA1540, Lot Number 22DBP691; DYNDA1540, Lot Number 22ABU584; DYNDA1540, Lot Number 21BBI623; DYNDA1540, Lot Number 20LBU589; DYNDA1540, Lot Number 20KBL865; DYNDA1540, Lot Number 20JBP526; DYNDA1540, Lot Number 20IBD073; DYNDA1540, Lot Number 20HBT535; DYNDA1540, Lot Number 20HBQ630; DYNDA1540, Lot Number 20HBB154; DYNDA1540, Lot Number 2019050290; DYNDA1540, Lot Number 2019061890; DYNDA1540, Lot Number 2019071290; DYNDA2499, Lot Number 21JBI254 ; DYNDA2519, Lot Number 22FBC352 ; DYNDA2519H , Lot Number 22FBC352 ; DYNDA3076, Lot Number 24ABU746 ; DYNDC3282, Lot Number 23CLA266 ; DYNDC3282, Lot Number 23DLA289 ; DYNDC3282, Lot Number 23FLA594 ; DYNDC3282A , Lot Number 23HLA208 ; DYNDC3282A , Lot Number 23ILA470 ; DYNDC3282B , Lot Number 23LLA874 ; DYNDC3282B , Lot Number 24CLA486 ; DYNJ0618280G , Lot Number 19BBA500 ; DYNJ0618280G , Lot Number 19BBK048 ; DYNJ0618280I , Lot Number 21HBF705 ; DYNJ0618280I , Lot Number 22EBJ300 ; DYNJ0618280I , Lot Number 19PBC248 ; DYNJ0618280I , Lot Number 19HBJ382 ; DYNJ0618280I , Lot Number 20BBX426 ; DYNJ0618280I , Lot Number 20DBN589 ; DYNJ0618280I , Lot Number 20EBF905 ; DYNJ0618280I , Lot Number 20IBA358 ; DYNJ0618280I , Lot Number 20IBJ312 ; DYNJ0618280I , Lot Number 20JBO345 ; DYNJ0618280J , Lot Number 22LBE471 ; DYNJ0618280J , Lot Number 23GBW260 ; DYNJ0618280J , Lot Number 23KBE106 ; DYNJ0738967A , Lot Number 19ABK292 ; DYNJ0738967A , Lot Number 19ABS637 ; DYNJ0738967A , Lot Number 19BBC096 ; DYNJ0738967A , Lot Number 19FBG026 ; DYNJ0738967A , Lot Number 19GBT425 ; DYNJ0738967A , Lot Number 19IBM307 ; DYNJ0738967A , Lot Number 19KBP191 ; DYNJ0738967A , Lot Number 20ABR041 ; DYNJ0738967A , Lot Number 20BBP817 ; DYNJ0738967A , Lot Number 20CBU110 ; DYNJ0738967A , Lot Number 20DBV286 ; DYNJ0738967A , Lot Number 20EBF979 ; DYNJ0738967A , Lot Number 20EBL088 ; DYNJ0738967A , Lot Number 20FBH972 ; DYNJ0738967A , Lot Number 20HBJ232 ; DYNJ28988I , Lot Number 23FLA367 ; DYNJ28988I , Lot Number 23GLA394 ; DYNJ28988I , Lot Number 23GLB068 ; DYNJ28988I , Lot Number 23HLA778 ; DYNJ28988I , Lot Number 23JLA349 ; DYNJ28988I , Lot Number 23JLB091 ; DYNJ28988I , Lot Number 23LLA861 ; DYNJ28988I , Lot Number 24BLA093 ; DYNJ28988I , Lot Number 23LLA359 ; DYNJ28988I , Lot Number 24CLA351 ; DYNJ36311A , Lot Number 19BKC718 ; DYNJ36311A , Lot Number 19CKC109 ; DYNJ43804A , Lot Number 23ABS693 ; DYNJ43804A , Lot Number 23DBJ631 ; DYNJ43804A , Lot Number 23GBS752 ; DYNJ43804A , Lot Number 23HBR871 ; DYNJ43804A , Lot Number 23KBE834 ; DYNJ43804A , Lot Number 23LBL776 ; DYNJ44258G , Lot Number 21ADB154 ; DYNJ46187D , Lot Number 23IMH258 ; DYNJ46187D , Lot Number 23LMD118 ; DYNJ53220B , Lot Number 22LMF612 ; DYNJ53220B , Lot Number 23BMH755 ; DYNJ53220B , Lot Number 23DMB617 ; DYNJ53220B , Lot Number 23EME353 ; DYNJ53220B , Lot Number 23FMC893 ; DYNJ53220B , Lot Number 23FMJ703 ; DYNJ53220B , Lot Number 23IMH249 ; DYNJ53220B , Lot Number 23KMA406 ; DYNJ53220B , Lot Number 24AMC542 ; DYNJ64857A , Lot Number 23GMB325 ; DYNJ68561, Lot Number 21GBT186 ; DYNJ68561, Lot Number 21HBN324 ; DYNJ68561, Lot Number 21IBF299 ; DYNJ68561, Lot Number 21JBU945 ; DYNJ68561, Lot Number 21KBR048 ; DYNJ68561, Lot Number 22ABE326 ; DYNJ68561, Lot Number 22CBZ837 ; DYNJ68561, Lot Number 22EBR300 ; DYNJ68561, Lot Number 22GBR532 ; DYNJ68561, Lot Number 22IBA354 ; DYNJ68561, Lot Number 22KBA954 ; DYNJ68561, Lot Number 23BBD411 ; DYNJ68561, Lot Number 23CBR350 ; DYNJ68561, Lot Number 23DBJ393 ; DYNJ68561, Lot Number 23EBJ138 ; DYNJ68561, Lot Number 23FBI706 ; DYNJ68561, Lot Number 23GBK621 ; DYNJ68561, Lot Number 23IBL911 ; DYNJ68561, Lot Number 23KBJ288 ; DYNJ68561, Lot Number 23LBN184 ; DYNJ68561, Lot Number 21CBA125 ; DYNJ68561, Lot Number 21EBO241 ; DYNJ81659A , Lot Number 22KBK040 ; DYNJ84247, Lot Number 23DBF655 ; DYNJ84247, Lot Number 23KBO915 ; DYNJ85036, Lot Number 23IBO065 ; DYNJ900073C, Lot Number 23GMG877 ; DYNJ900073C, Lot Number 23IMB632 ; DYNJ900073C, Lot Number 23JMH955 ; DYNJ900073C, Lot Number 23KME142 ; DYNJ906282C, Lot Number 23EMH718 ; DYNJ906282C, Lot Number 23EMI365 ; DYNJ906282C, Lot Number 23GMG364 ; DYNJ906282C, Lot Number 23GMH729 ; DYNJ906282C, Lot Number 23KMC248 ; DYNJ906282C, Lot Number 23LME074 ; DYNJ909261A, Lot Number 24ABA886 ; DYNJ909403 , Lot Number 23BMH377 ; DYNJ909403 , Lot Number 23CMC605 ; DYNJ909403 , Lot Number 23CMG979 ; DYNJ909403 , Lot Number 23EMD386 ; DYNJ909403 , Lot Number 23HMC288 ; DYNJ909403 , Lot Number 23HMI268 ; DYNJ909403 , Lot Number 23JMJ496 ; DYNJ909403 , Lot Number 23LMG588 ; DYNJRA1280A, Lot Number 19DDB134 ; DYNJRA1280A, Lot Number 19EDA093 ; DYNJRA1280A, Lot Number 19FDA364 ; DYNJRA1280A, Lot Number 19GDB114 ; DYNJRA1424 , Lot Number 19SBF926 ; DYNJRA1424 , Lot Number 22LBJ843 ; DYNJRA1424 , Lot Number 19JBQ794 ; DYNJRA1424 , Lot Number 19JBU300 ; DYNJRA1424 , Lot Number 19KBU269 ; DYNJRA1424 , Lot Number 19KBU874 ; DYNJRA1424 , Lot Number 23DBO709 ; DYNJRA1424 , Lot Number 23JBB394 ; DYNJRA1424 , Lot Number 23JBO140 ; DYNJRA1424H, Lot Number 19SBF926 ; DYNJRA1424H, Lot Number 22LBJ843 ; DYNJRA1424H, Lot Number 19JBQ794 ; DYNJRA1424H, Lot Number 19JBU300 ; DYNJRA1424H, Lot Number 19KBU269 ; DYNJRA1424H, Lot Number 19KBU874 ; DYNJRA1424H, Lot Number 23DBO709 ; DYNJRA1424H, Lot Number 23JBB394 ; DYNJRA1424H, Lot Number 23JBO140 ; DYNJRA1498B, Lot Number 23LBH684; DYNJRA1498B, Lot Number 23KBM001; DYNJRA1498B, Lot Number 23HBR192; DYNJRA1498B, Lot Number 23HBQ223; DYNJRA1583C, Lot Number 22IBA106 ; DYNJRA1583C, Lot Number 22IBM619 ; DYNJRA1583C, Lot Number 22JBG212 ; DYNJRA1583C, Lot Number 23ABG207 ; DYNJRA1760 , Lot Number 21FBK824 ; DYNJRA1760 , Lot Number 21GBQ183 ; DYNJRA1760 , Lot Number 21HBG758 ; DYNJRA1760 , Lot Number 21JBD045 ; DYNJRA1760 , Lot Number 21KBF195 ; DYNJRA1760 , Lot Number 21CBP879 ; DYNJRA1774 , Lot Number 21EBN794 ; DYNJRA1783 , Lot Number 21HBO497 ; DYNJRA1783 , Lot Number 21JBT912 ; DYNJRA1783 , Lot Number 22ABA947 ; DYNJRA1783 , Lot Number 21DBU350 ; DYNJRA1783 , Lot Number 22LMJ331 ; DYNJRA1783 , Lot Number 23DMA884 ; DYNJRA1946A, Lot Number 23IBN848 ; PHS627837003 , Lot Number 21GBD048 ; PHS627837003 , Lot Number 21IBK924 ; PHS627837003 , Lot Number 21JBI944 ; PHS627837003 , Lot Number 21JBZ984 ; PHS627837003 , Lot Number 21KBQ074 ; PHS627837003 , Lot Number 21LBI926 ; PHS627837003 , Lot Number 20LBL907 ; PHS627837003 , Lot Number 21ABL868 ; PHS627837003 , Lot Number 21CBY701 ; PHS627837003A, Lot Number 22EBS057 ; PHS627837003A, Lot Number 22HBO070 ; PHS627837003A, Lot Number 22IBF110 ; PHS627837003A, Lot Number 22KBL329 ; PHS627837003A, Lot Number 23DBN960 ; PHS627837003A, Lot Number 23FBP926 ; PHS627837003A, Lot Number 23HBT307 ; PHS627837003A, Lot Number 23JBL440 ; PHS627837003A, Lot Number 23JBY708 ; PHS627837003A, Lot Number 23KBP182

Distribution pattern

Worldwide distribution.

device · product 45 of 81

Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B

Z-3025-2024
Recall number
Z-3025-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ0281516M , Lot Number 19EBW985 ; DYNJ0281516M , Lot Number 19FBS033 ; DYNJ0281516M , Lot Number 19GBE356 ; DYNJ0281516M , Lot Number 19GBN481 ; DYNJ0281516M , Lot Number 19SBC273 ; DYNJ0281516M , Lot Number 19VBH540 ; DYNJ0281516M , Lot Number 19LBS319 ; DYNJ0281516M , Lot Number 20ABZ597 ; DYNJ0281516M , Lot Number 20DBH983 ; DYNJ0281516M , Lot Number 20FBJ183 ; DYNJ0281516M , Lot Number 20HBK308 ; DYNJ0281516M , Lot Number 20JBZ789 ; DYNJ0281516M , Lot Number 20LBU288 ; DYNJ0281516M , Lot Number 21CBD769 ; DYNJ0281516M , Lot Number 21EMF053 ; DYNJ0281516M , Lot Number 21GMB207 ; DYNJ0281516M , Lot Number 21HMD725 ; DYNJ0281516M , Lot Number 21IMF128 ; DYNJ0281516M , Lot Number 21LMC143 ; DYNJ0281516M , Lot Number 22AMF940 ; DYNJ0281516M , Lot Number 22CMC800 ; DYNJ0281516M , Lot Number 22CMD981 ; DYNJ0281516M , Lot Number 22EMG839 ; DYNJ0281516M , Lot Number 22EMH435 ; DYNJ0281516M , Lot Number 22HMC805 ; DYNJ0281516M , Lot Number 22JMA630 ; DYNJ0281516M , Lot Number 22LMA629 ; DYNJ0281516M , Lot Number 23AMB717 ; DYNJ0281516M , Lot Number 23BMI443 ; DYNJ0281516M , Lot Number 23DMG317 ; DYNJ0281516M , Lot Number 23FMC971 ; DYNJ0281516M , Lot Number 23GMD118 ; DYNJ0281516M , Lot Number 23HMH453 ; DYNJ0281516M , Lot Number 23JMB170 ; DYNJ0281516M , Lot Number 23KME384 ; DYNJ0281516M , Lot Number 19AKA641 ; DYNJ0281516M , Lot Number 19BKD684 ; DYNJ0281516M , Lot Number 19DKC345 ; DYNJ0484979B , Lot Number 18LBO447 ; DYNJ0484979B , Lot Number 19CBU327

Distribution pattern

Worldwide distribution.

device · product 46 of 81

Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A

Z-3026-2024
Recall number
Z-3026-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDS1130A, Lot Number 21JBG946

Distribution pattern

Worldwide distribution.

device · product 47 of 81

Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Number DT19245; 6) BIOPSY KIT, Pack Number DYNDA1466A; 7) BIOPSY KIT, Pack Number DYNDA1466A; 8) CATH REMOVAL, Pack Number DYNDA1733B; 9) CATH REMOVAL, Pack Number DYNDA1814; 10) CATH REMOVAL, Pack Number DYNDA1814; 11) CATH REMOVAL, Pack Number DYNDA1814; 12) CATH REMOVAL, Pack Number DYNDA1814; 13) CATH REMOVAL, Pack Number DYNDA1814; 14) CATH REMOVAL, Pack Number DYNDA1814; 15) CATH REMOVAL, Pack Number DYNDA1814; 16) CATH REMOVAL, Pack Number DYNDA1814; 17) SHUNT TRAY, Pack Number DYNDA2725; 18) PORT ACCESS KIT, Pack Number DYNDC2945; 19) PORT ACCESS KIT, Pack Number DYNDC2945; 20) PORT ACCESS KIT, Pack Number DYNDC2945; 21) PORT ACCESS KIT, Pack Number DYNDC2945; 22) PORT ACCESS KIT, Pack Number DYNDC2945; 23) PORT ACCESS KIT, Pack Number DYNDC2945; 24) PORT ACCESS KIT, Pack Number DYNDC2945; 25) PORT ACCESS KIT, Pack Number DYNDC2945; 26) PORT ACCESS KIT, Pack Number DYNDC2945; 27) PORT ACCESS KIT, Pack Number DYNDC2945; 28) ARTHROGRAM TRAY, Pack Number DYNDH1113; 29) BIOPSY TRAY, Pack Number DYNDH1137C; 30) BIOPSY PACK, Pack Number DYNDH1248; 31) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 32) MYELOGRAM TRAY, Pack Number DYNDH1531; 33) BIOPSY PACK, Pack Number DYNDL1462B; 34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 36) PORT ACCESS TRAY, Pack Number EBSI1241; 37) PORT ACCESS TRAY, Pack Number EBSI1241; 38) PORT ACCESS TRAY, Pack Number EBSI1241; 39) PORT ACCESS TRAY, Pack Number EBSI1241; 40) PORT ACCESS TRAY, Pack Number EBSI1241; 41) PORT ACCESS TRAY, Pack Number EBSI1241; 42) PORT ACCESS TRAY, Pack Number EBSI1241; 43) PORT ACCESS TRAY, Pack Number EBSI1241; 44) PORT ACCESS TRAY, Pack Number EBSI1241; 45) PORT ACCESS TRAY, Pack Number EBSI1241; 46) PORT ACCESS TRAY, Pack Number EBSI1241; 47) PORT ACCESS TRAY, Pack Number EBSI1241; 48) PORT ACCESS TRAY, Pack Number EBSI1241; 49) PORT ACCESS TRAY, Pack Number EBSI1241; 50) PORT ACCESS TRAY, Pack Number EBSI1241; 51) PORT ACCESS TRAY, Pack Number EBSI1241; 52) PORT ACCESS TRAY, Pack Number EBSI1241; 53) PORT ACCESS TRAY, Pack Number EBSI1241; 54) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 55) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 58) OB DELIVERY TRAY, Pack Number MNS10875A; 59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 60) OB DELIVERY SET, Pack Number MNS3355; 61) LUMBAR TRAY, Pack Number SPEC0177; 62) 22G FACET TRAY, Pack Number SPEC0265A; 63) FINE LACERATION KIT, Pack Number SUT19360; 64) LACERATION TRAY, Pack Number SUT20955; 65) LACERATION TRAY, Pack Number SUT3780; 66) LACERATION TRAY, Pack Number SUT3780; 67) SUTURING SET, Pack Number SUT4020

Z-3027-2024
Recall number
Z-3027-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

ART245C, Lot Number 2023083090; CHT1900, Lot Number 2020092590; CHT560, Lot Number 2020110590; CHT705, Lot Number 2023011790; DT19245 , Lot Number 21JBN311 ; DYNDA1466A, Lot Number 2021111090; DYNDA1466A, Lot Number 2023091890; DYNDA1733B, Lot Number 2019021950; DYNDA1814, Lot Number 2018103050; DYNDA1814, Lot Number 2018121450; DYNDA1814, Lot Number 2019010950; DYNDA1814, Lot Number 2019021950; DYNDA1814, Lot Number 2019041850; DYNDA1814, Lot Number 2019112250; DYNDA1814, Lot Number 2020031350; DYNDA1814, Lot Number 2020100801; DYNDA2725, Lot Number 2023011790; DYNDC2945, Lot Number 2020071090; DYNDC2945, Lot Number 2020090990; DYNDC2945, Lot Number 2020110590; DYNDC2945, Lot Number 2020122890; DYNDC2945, Lot Number 2021081890; DYNDC2945, Lot Number 2021120890; DYNDC2945, Lot Number 2022121290; DYNDC2945, Lot Number 2023011090; DYNDC2945, Lot Number 2023080790; DYNDC2945, Lot Number 2023091890; DYNDH1113, Lot Number 2020031350; DYNDH1137C, Lot Number 2021011890; DYNDH1248, Lot Number 2019021950; DYNDH1359, Lot Number 2023080790; DYNDH1531, Lot Number 2022020990; DYNDL1462B, Lot Number 2019010950; EBSI1039B, Lot Number 2023083090; EBSI1039B, Lot Number 2023110390; EBSI1241, Lot Number 2019120590; EBSI1241, Lot Number 2020040390; EBSI1241, Lot Number 2020061990; EBSI1241, Lot Number 2020092590; EBSI1241, Lot Number 2020111390; EBSI1241, Lot Number 2021011890; EBSI1241, Lot Number 2021041290; EBSI1241, Lot Number 2021091590; EBSI1241, Lot Number 2021111090; EBSI1241, Lot Number 2021120690; EBSI1241, Lot Number 2022020990; EBSI1241, Lot Number 2022042290; EBSI1241, Lot Number 2022072690; EBSI1241, Lot Number 2022082990; EBSI1241, Lot Number 2022101390; EBSI1241, Lot Number 2023011790; EBSI1241, Lot Number 2023090690; EBSI1241, Lot Number 2023110390; EBSI1453, Lot Number 2022022180; EBSI1453, Lot Number 2022032880; EBSI1453A, Lot Number 2022093090; EBSI1453A, Lot Number 2023083090; MNS10875A, Lot Number 2023011790; MNS12150, Lot Number 2022121290; MNS3355, Lot Number 2020071090; SPEC0177, Lot Number 2019120590; SPEC0265A, Lot Number 2019120590; SUT19360, Lot Number 2022042290; SUT20955, Lot Number 2020092590; SUT3780, Lot Number 2020061990; SUT3780, Lot Number 2020111390; SUT4020, Lot Number 2023091890

Distribution pattern

Worldwide distribution.

device · product 48 of 81

Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH; 3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ; 4) LACERATION TRAY , Pack Number DYNDL1495A ; 5) LACERATION TRAY , Pack Number DYNDL1495AH; 6) LACERATION TRAY , Pack Number DYNDL1807B ; 7) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963; 8) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963H ; 9) LACERATION TRAY , Pack Number DYNDL1965A ; 10) STERILE RESUTURE PACK, Pack Number DYNDL1980A; 11) STERILE RESUTURE PACK, Pack Number DYNDL1980AH; 12) LACERATION TRAY , Pack Number DYNDL1981; 13) LACERATION TRAY , Pack Number DYNDL1985; 14) SUTURE TRAY , Pack Number DYNDL1986; 15) FGH FLOOR KIT , Pack Number DYNDL1989; 16) LACERATION KIT, Pack Number DYNDL1991; 17) LACERATION KIT, Pack Number DYNDL1992; 18) LACERATION KIT, Pack Number DYNDL1992H ; 19) ER LACERATION TRAY, Pack Number DYNDL1993; 20) LACERATION TRAY , Pack Number DYNDL1994; 21) CLOSURE PACK-LF , Pack Number DYNJ0807503N ; 22) CLOSING BUNDLE, Pack Number DYNJ52157I ; 23) PREMIUM CLOSUREPLUS PACK, Pack Number DYNJ54326A ; 24) ABD CLOSURE PACK, Pack Number DYNJ56987C ; 25) CLOSING PACK, Pack Number DYNJ57577A ; 26) SURGERY CLOSING KIT , Pack Number DYNJ67429B ; 27) CLOSING PACK, Pack Number DYNJ68267B ; 28) MICRODISECTOMY PACK , Pack Number DYNJ80585B ; 29) PREP TRAY , Pack Number DYNJRA1583D; 30) NECESSAIRES A POINT DE SUTURES, Pack Number M101498; 31) MAJOR LACERATION PACK-LF, Pack Number PHS751688G; 32) IR SUTURE PACK-LF , Pack Number PHS863717D ; 33) FINE LACERATION KIT , Pack Number SUT17215A; 34) MINOR LACERATION TRAY , Pack Number SUT18200 ; 35) LACERATION TRAY, Pack Number SUT20285A; 36) LACERATION TRAY W/ LIDOCAINE, Pack Number SUT20595A; 37) SNAG FREE LACERATION TRAY, Pack Number SUT21665; 38) LACERATION TRAY , Pack Number SUT21710 ; 39) LACERATION REPAIR TRAY, Pack Number SUT21780 ; 40) SNAG FREE LACERATION TRAY , Pack Number SUT21825

Z-3028-2024
Recall number
Z-3028-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYKMBNDL200A , Lot Number 22KBD675 ; DYKMBNDL200A , Lot Number 23KBA331 ; DYKMBNDL200AH, Lot Number 22KBD675 ; DYKMBNDL200AH, Lot Number 23KBA331 ; DYNDA2415B , Lot Number 23JLA114 ; DYNDA2415B , Lot Number 24BLB045 ; DYNDL1495A , Lot Number 22LBJ768 ; DYNDL1495A , Lot Number 23ABG899 ; DYNDL1495A , Lot Number 23CBF146 ; DYNDL1495A , Lot Number 23DBO301 ; DYNDL1495A , Lot Number 23EBC524 ; DYNDL1495A , Lot Number 23EBR564 ; DYNDL1495A , Lot Number 23GBC601 ; DYNDL1495A , Lot Number 23HBF407 ; DYNDL1495A , Lot Number 23IBR368 ; DYNDL1495A , Lot Number 23KBF026 ; DYNDL1495AH, Lot Number 22LBJ768 ; DYNDL1495AH, Lot Number 23ABG899 ; DYNDL1495AH, Lot Number 23CBF146 ; DYNDL1495AH, Lot Number 23DBO301 ; DYNDL1495AH, Lot Number 23EBC524 ; DYNDL1495AH, Lot Number 23EBR564 ; DYNDL1495AH, Lot Number 23GBC601 ; DYNDL1495AH, Lot Number 23HBF407 ; DYNDL1495AH, Lot Number 23IBR368 ; DYNDL1495AH, Lot Number 23KBF026 ; DYNDL1807B , Lot Number 21JBR532 ; DYNDL1963, Lot Number 22JMG284 ; DYNDL1963H , Lot Number 22JMG284 ; DYNDL1965A , Lot Number 21JBJ528 ; DYNDL1980A, Lot Number 23KBE409; DYNDL1980AH, Lot Number 23KBE409; DYNDL1981, Lot Number 22GBU753 ; DYNDL1981, Lot Number 22LBS274 ; DYNDL1981, Lot Number 23ABL575 ; DYNDL1981, Lot Number 23BBJ949 ; DYNDL1981, Lot Number 23CBG983 ; DYNDL1985, Lot Number 22JBN831 ; DYNDL1985, Lot Number 23CBQ478 ; DYNDL1985, Lot Number 23DBF367 ; DYNDL1986, Lot Number 22LBJ084 ; DYNDL1986, Lot Number 23FBO474 ; DYNDL1986, Lot Number 23GBE045 ; DYNDL1989, Lot Number 23DBN197 ; DYNDL1989, Lot Number 23FBB552 ; DYNDL1989, Lot Number 23GBR197 ; DYNDL1991, Lot Number 23IMG395 ; DYNDL1992, Lot Number 23IBH341 ; DYNDL1992, Lot Number 23KBA670 ; DYNDL1992H , Lot Number 23IBH341 ; DYNDL1992H , Lot Number 23KBA670 ; DYNDL1993, Lot Number 23JBP617 ; DYNDL1994, Lot Number 23KBF825 ; DYNDL1994, Lot Number 23LBV214 ; DYNJ0807503N , Lot Number 23FME235 ; DYNJ52157I , Lot Number 23EBQ422 ; DYNJ52157I , Lot Number 23FBO768 ; DYNJ52157I , Lot Number 23HBG369 ; DYNJ52157I , Lot Number 23KBJ323 ; DYNJ54326A , Lot Number 23AME179 ; DYNJ54326A , Lot Number 23AME557 ; DYNJ56987C , Lot Number 22ABW610 ; DYNJ56987C , Lot Number 22DBL196 ; DYNJ56987C , Lot Number 22FBT303 ; DYNJ56987C , Lot Number 22GBV087 ; DYNJ56987C , Lot Number 22HBA077 ; DYNJ56987C , Lot Number 22HBG952 ; DYNJ56987C , Lot Number 22JBP791 ; DYNJ56987C , Lot Number 23DBR364 ; DYNJ56987C , Lot Number 23EBO053 ; DYNJ56987C , Lot Number 23FBJ914 ; DYNJ57577A , Lot Number 23KBB899 ; DYNJ67429B , Lot Number 23HBM022 ; DYNJ67429B , Lot Number 23LBH577 ; DYNJ68267B , Lot Number 23JBS852 ; DYNJ68267B , Lot Number 23LBC084 ; DYNJ80585B , Lot Number 23JBO457 ; DYNJRA1583D, Lot Number 23BBO987 ; DYNJRA1583D, Lot Number 23CBK029 ; DYNJRA1583D, Lot Number 23DBO695 ; DYNJRA1583D, Lot Number 23EBQ098 ; DYNJRA1583D, Lot Number 23GBE489 ; DYNJRA1583D, Lot Number 23HBT552 ; DYNJRA1583D, Lot Number 23JBM501 ; DYNJRA1583D, Lot Number 23JBO381 ; DYNJRA1583D, Lot Number 23JBW239 ; M101498, Lot Number 23FBL279 ; M101498, Lot Number 23HBT746 ; M101498, Lot Number 23IBM609 ; M101498, Lot Number 23JBY348 ; PHS751688G, Lot Number 22GME957; PHS751688G , Lot Number 22JME303 ; PHS751688G , Lot Number 22LMA157 ; PHS751688G , Lot Number 23EMC745 ; PHS751688G , Lot Number 23GMF501 ; PHS751688G , Lot Number 23HMI688 ; PHS751688G , Lot Number 23IMI261 ; PHS751688G , Lot Number 23LMG060 ; PHS863717D , Lot Number 23HMA623 ; SUT17215A, Lot Number 21JBR416 ; SUT17215A, Lot Number 21LBD248 ; SUT17215A, Lot Number 21LBH077 ; SUT17215A, Lot Number 22ABU681 ; SUT17215A, Lot Number 22BBH582 ; SUT17215A, Lot Number 22FBV156 ; SUT17215A, Lot Number 22GBD888 ; SUT17215A, Lot Number 22HBN609 ; SUT17215A, Lot Number 22KBG540 ; SUT17215A, Lot Number 23FBF413 ; SUT17215A, Lot Number 23IBD809 ; SUT17215A, Lot Number 23IBM566 ; SUT17215A, Lot Number 23KBL557 ; SUT18200 , Lot Number 22FBT088 ; SUT18200 , Lot Number 22GBL911 ; SUT18200 , Lot Number 22HBJ926 ; SUT20285A, Lot Number 23LBS386; SUT20285A, Lot Number 23JBS506; SUT20285A, Lot Number 23IBI056; SUT20285A, Lot Number 23GBW843; SUT20285A, Lot Number 23FBE166; SUT20285A, Lot Number 23EBU296; SUT20285A, Lot Number 23LBS386; SUT20285A, Lot Number 23JBS506; SUT20285A, Lot Number 23IBI056; SUT20285A, Lot Number 23GBW843; SUT20285A, Lot Number 23FBE166; SUT20285A, Lot Number 23EBU296; SUT20595A, Lot Number 24ABC621; SUT20595A, Lot Number 23JBQ538; SUT20595A, Lot Number 23HBK602; SUT20595A, Lot Number 23FBR371; SUT20595A, Lot Number 23DBE268; SUT20595A, Lot Number 23ABS718; SUT21665, Lot Number 24ABU830; SUT21665, Lot Number 23HBW402; SUT21665, Lot Number 22LBM554; SUT21665, Lot Number 22LBH669; SUT21665, Lot Number 22BBP538; SUT21710 , Lot Number 22EBP025 ; SUT21710 , Lot Number 22KBU033 ; SUT21710 , Lot Number 22LBO669 ; SUT21710 , Lot Number 23EBA694 ; SUT21710 , Lot Number 23FBK814 ; SUT21710 , Lot Number 23HBU140 ; SUT21710 , Lot Number 23KBO838 ; SUT21710 , Lot Number 23KBV154 ; SUT21780 , Lot Number 23HBJ842 ; SUT21825 , Lot Number 23JBM130

Distribution pattern

Worldwide distribution.

device · product 49 of 81

Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1514; 6) BIOPSY KIT, Pack Number DYNDH1570; 7) MYELOGRAM TRAY, Pack Number DYNDH1574; 8) BONE MARROW ASPIRATION AND BIOPSY, Pack Number DYNDH1596; 9) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1638; 10) BIOPSY PACK, Pack Number DYNDH1699; 11) LACERATION TRAY, Pack Number DYNDL1159B; 12) SUTURE TRAY, Pack Number DYNDS1064B; 13) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 15) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 16) ARTHROGRAM PACK, Pack Number P241108; 17) PACK BONE MARROW BIOPSY, Pack Number P268481; 18) BIOPSY BASIC PACK, Pack Number P784604; 19) ARTHROGRAM TRAY-LF, Pack Number SPEC0061B; 20) BIOPSY TRAY, Pack Number SPEC0095; 21) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 22) BONE MARROW TRAY, Pack Number SPEC0255; 23) ARTHROGRAM TRAY-LF, Pack Number SPEC0400

Z-3029-2024
Recall number
Z-3029-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DM645, Lot Number 2019120980; DYNDC1960A, Lot Number 2022040790; DYNDH1319, Lot Number 2020122250; DYNDH1324A, Lot Number 2020122250; DYNDH1514, Lot Number 2020040250; DYNDH1514, Lot Number 2020050750; DYNDH1570, Lot Number 2022011450; DYNDH1574, Lot Number 2022011450; DYNDH1596, Lot Number 2020122250; DYNDH1596, Lot Number 2022092090; DYNDH1638, Lot Number 2021062150; DYNDH1638, Lot Number 2021092350; DYNDH1638, Lot Number 2022011450; DYNDH1638, Lot Number 2022060750; DYNDH1699, Lot Number 2022060750; DYNDL1159B, Lot Number 2019022580; DYNDS1064B, Lot Number 2019062480; DYNDS1064B, Lot Number 2019120980; DYNJTS0214, Lot Number 2020113050; DYNJTS0214, Lot Number 2021012850; DYNJTS0214, Lot Number 2021050750; DYNJTS0214, Lot Number 2021082650; DYNJTS0214, Lot Number 2021102550; DYNJTS0214, Lot Number 2021111290; DYNJTS0214, Lot Number 2022040790; DYNJTS0214, Lot Number 2022052690; DYNJTS0214, Lot Number 2022080390; DYNJTS0214, Lot Number 2022092090; DYNJTS0214, Lot Number 2022102190; DYNJTS0214, Lot Number 2023100990; DYNJTS0214, Lot Number 2024010890; DYNJTS4306, Lot Number 2022011450; IVS3320, Lot Number 2021111290; P241108, Lot Number 2021012850; P268481, Lot Number 2022060750; P784604, Lot Number 2019120980; SPEC0061B, Lot Number 2021062150; SPEC0095, Lot Number 2020113050; SPEC0095, Lot Number 2022060750; SPEC0149, Lot Number 2020113050; SPEC0255, Lot Number 2019022580; SPEC0255, Lot Number 2019032580; SPEC0255, Lot Number 2019062480; SPEC0255, Lot Number 2019120980; SPEC0255, Lot Number 2019121080; SPEC0255, Lot Number 2020012080; SPEC0400, Lot Number 2020113050

Distribution pattern

Worldwide distribution.

device · product 50 of 81

Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number SPEC0130B; 6) BIOPSY PACK SM, Pack Number DYNDH1093; 7) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 8) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 9) LACERATION TRAY, Pack Number DYNDL1250C; 10) PULL D/C PACK, Pack Number DYNDA2080; 11) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 12) OB DELIVERY SET, Pack Number MNS3355; 13) SUTURING SET, Pack Number SUT4020; 14) 22G FACET TRAY, Pack Number SPEC0265A; 15) ARTHROGRAM TRAY, Pack Number DYNDH1349; 16) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 17) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496; 18) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 19) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 20) BREAST BIOPSY KIT, Pack Number DYNDH1706; 21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 22) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 23) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number DYNDH1755; 24) BREAST BIOPSY, Pack Number DYNDH1518A; 25) PORT INSERTION KIT, Pack Number MNS11590; 26) CORE BIOPSY TRAY, Pack Number SPEC0083B; 27) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 28) BREAST CENTER BIOPSY TRAY, Pack Number DYNDH1519; 29) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 30) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 31) ARTHROGRAM TRAY, Pack Number DYNDH1134; 32) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 33) BIOPSY TRAY, Pack Number DYNDH1269; 34) BIOPSY BASIC PACK, Pack Number DYNDH1588

Z-3030-2024
Recall number
Z-3030-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

BT1095 , Lot Number 21HBO851 ; BT1095 , Lot Number 21JBA498 ; BT1095 , Lot Number 21KBS041 ; BT1095 , Lot Number 21LBI316 ; BT1095 , Lot Number 22IBE255 ; BT1095 , Lot Number 23CBL036 ; BT1095 , Lot Number 23DBE633 ; BT1095 , Lot Number 21ABU603 ; MNS5070, Lot Number 23LBC489; MNS5070, Lot Number 23HBL700; MNS5070, Lot Number 23EBJ365; SPEC0058A, Lot Number 2018110290; DYNDH1142A, Lot Number 2018120590; SPEC0130B, Lot Number 2018121290; SPEC0058A, Lot Number 2019012490; DYNDH1093, Lot Number 2019012490; SPEC0130B, Lot Number 2019020590; DYNDH1227A, Lot Number 2019020590; DYNDH1304A, Lot Number 2019040990; DYNDL1250C, Lot Number 2019040990; DYNDH1227A, Lot Number 2019040990; DYNDL1250C, Lot Number 2019040990; DYNDA2080, Lot Number 2019040990; SPEC0058A, Lot Number 2019060690; SPEC0130B, Lot Number 2019062890; SPEC0058A, Lot Number 2019070290; DYNDH1359, Lot Number 2019070290; MNS3355, Lot Number 2019062890; SPEC0130B, Lot Number 2019081590; SUT4020, Lot Number 2019081590; SPEC0265A, Lot Number 2019081590; DYNDH1349, Lot Number 2019081590; DYNDH1304A, Lot Number 2019112190; SPEC0196B, Lot Number 2019112190; DYNDH1349, Lot Number 2019112190; SPEC0130B, Lot Number 2019121190; DYNDH1496, Lot Number 2019122790; DYNDH1496, Lot Number 2020013190; DYNDH1496, Lot Number 2020120290; DYNDH1496, Lot Number 2021022590; SPEC0130C, Lot Number 2021051890; MNS6496, Lot Number 2021051890; SPEC0130C, Lot Number 2021071290; SPEC0130C, Lot Number 2021082490; SPEC0130C, Lot Number 2021091390; DYNDH1706, Lot Number 2022021550; SPEC0130C, Lot Number 2022020290; SPEC0130C, Lot Number 2022032990; DYNJTS0018A, Lot Number 2022032990; DYNDC2859A, Lot Number 2022032990; DYNDH1755, Lot Number 2022061050; DYNDH1518A, Lot Number 2022061050; SPEC0130C, Lot Number 2022081690; SPEC0130C, Lot Number 2022120290; MNS11590, Lot Number 2022120290; SPEC0083B, Lot Number 2022120290; DYNDH1798, Lot Number 2022120290; DYNDH1519, Lot Number 2022120690; CHT500, Lot Number 2022120690; DYNDH1519, Lot Number 2023020390; SPEC0130C, Lot Number 2023053190; DYNDH1519, Lot Number 2023081590; DYNDH1257, Lot Number 2018072450; DYNDH1257, Lot Number 2018080950; DYNDH1257, Lot Number 2018100350; DYNDH1257, Lot Number 2018113050; DYNDH1134, Lot Number 2018113050; DYNDH1319, Lot Number 2019011750; DYNDH1257, Lot Number 2019032150; DYNDH1319, Lot Number 2019073050; DYNDH1319, Lot Number 2019093050; DYNDH1319, Lot Number 2019103150; DYNDH1257, Lot Number 2020020350; DYNDH1257, Lot Number 2020033150; DYNDH1319, Lot Number 2020072050; DYNDH1269, Lot Number 2020072050; DYNDH1257, Lot Number 2020102950; DYNDH1319, Lot Number 2021021950; DYNDH1257, Lot Number 2021030350; DYNDH1257, Lot Number 2021120750; DYNDH1257, Lot Number 2022051350; DYNDH1319, Lot Number 2022052650; DYNDH1588, Lot Number 2022052650

Distribution pattern

Worldwide distribution.

device · product 51 of 81

Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A

Z-3031-2024
Recall number
Z-3031-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

2008, Lot Number 23ABN325; DYNJAA10295A, Lot Number 22EBI496; DYNJAA10295A, Lot Number 22CBX850

Distribution pattern

Worldwide distribution.

device · product 52 of 81

Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206

Z-3032-2024
Recall number
Z-3032-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJSYR12CP, Lot Number 19ABK425 ; DYNJSYR12CP, Lot Number 19ABK443 ; 148056, Lot Number 24DMC306; 148056, Lot Number 23LMI229; 148056, Lot Number 23JMH148; 148056, Lot Number 23JMA243; 148056, Lot Number 23IMB662; 148056, Lot Number 23HMG815; 150206, Lot Number 23LME712

Distribution pattern

Worldwide distribution.

device · product 53 of 81

Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ; 3) SYRINGE KIT , Pack Number NAM0004; 4) SYR 10ML L/S, Pack Number OEM11623 ; 5) JAPAN 3ML SYRINGE , Pack Number SAMPCJ006; 6) JAPAN 5ML SYRINGE, Pack Number SAMPCJ007; 7) JAPAN 10ML SYRINGE, Pack Number SAMPCJ008; 8) JAPAN 20ML SYRINGE, Pack Number SAMPCJ009; 9) JAPAN 30ML SYRINGE, Pack Number SAMPCJ010; 10) JAPAN 60ML SYRINGE, Pack Number SAMPCJ011

Z-3033-2024
Recall number
Z-3033-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJSYCPP10R , Lot Number 22JBR164 ; DYNJSYCPP10Y , Lot Number 22JBR165 ; NAM0004, Lot Number 21DDB223 ; NAM0004, Lot Number 21HDC569 ; NAM0004, Lot Number 21IDB793 ; NAM0004, Lot Number 21JDA347 ; NAM0004, Lot Number 21LDA148 ; OEM11623 , Lot Number 21GBQ995 ; OEM11623 , Lot Number 22BBC557 ; OEM11623 , Lot Number 22CBH284 ; OEM11623 , Lot Number 19BBF348 ; OEM11623 , Lot Number 19DBI184 ; OEM11623 , Lot Number 22EBE833 ; OEM11623 , Lot Number 19QBB707 ; OEM11623 , Lot Number 19FBK375 ; OEM11623 , Lot Number 19GBY960 ; OEM11623 , Lot Number 19HBH787 ; OEM11623 , Lot Number 19HBO770 ; OEM11623 , Lot Number 23ABH043 ; OEM11623 , Lot Number 19KBX346 ; OEM11623 , Lot Number 19LBK179 ; OEM11623 , Lot Number 20BBC515 ; OEM11623 , Lot Number 20BBS501 ; OEM11623 , Lot Number 20CBB499 ; OEM11623 , Lot Number 20CBB674 ; OEM11623 , Lot Number 20FBA919 ; OEM11623 , Lot Number 20HBT942 ; OEM11623 , Lot Number 20LBK683 ; OEM11623 , Lot Number 20XBD345 ; OEM11623 , Lot Number 21FBG914 ; SAMPCJ006, Lot Number 24ADC130 ; SAMPCJ007, Lot Number 24ADC129; SAMPCJ008, Lot Number 24ADC128 ; SAMPCJ009, Lot Number 24ADC127 ; SAMPCJ010, Lot Number 24ADC126 ; SAMPCJ011, Lot Number 24ADC125

Distribution pattern

Worldwide distribution.

device · product 54 of 81

Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ58575C ; 6) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212H ; 7) FLAP HARVEST PACK, Pack Number DYNJ58575C

Z-3034-2024
Recall number
Z-3034-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYND30212, Lot Number 20CBV412 ; DYND30212H , Lot Number 20CBV412 ; DYNJ58575C, Lot Number 22FMF260; DYNJ58575C, Lot Number 22EMI154; DYNJ58575C , Lot Number 22JMF580 ; DYNJ65728A , Lot Number 21IBJ821 ; DYNJ65728A , Lot Number 21IBV204 ; DYNJ65728A , Lot Number 21JBE157 ; DYNJ82155A , Lot Number 23CBD960 ; DYNJ82155A , Lot Number 23CBH024 ; DYNJ82155A , Lot Number 23DBL430 ; DYNJ82155A , Lot Number 23EBI493 ; DYNJ82155A , Lot Number 23FBO135 ; DYNJ82155A , Lot Number 23FBO795 ; DYNJ82155A , Lot Number 23GBJ181 ; DYNJ82155A , Lot Number 23HBJ559 ; DYNJ82155A , Lot Number 23IBJ041 ; DYNJ82155A , Lot Number 23IBJ042 ; DYNJ85191, Lot Number 23JBP679

Distribution pattern

Worldwide distribution.

device · product 55 of 81

Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389

Z-3035-2024
Recall number
Z-3035-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYKA1389, Lot Number 21IMA285

Distribution pattern

Worldwide distribution.

device · product 56 of 81

Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5) KIT ANGIO CSTM-PROVIDENCE , Pack Number SAMP0545

Z-3036-2024
Recall number
Z-3036-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ0621408V, Lot Number 23ILB053; DYNJ0621408VH, Lot Number 23ILB053; DYNJ0864492A , Lot Number 21KMH585 ; DYNJ0864492AH, Lot Number 21KMH585 ; SAMP0545 , Lot Number 22GME387 ; SAMP0545 , Lot Number 22GME980

Distribution pattern

Worldwide distribution.

device · product 57 of 81

Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114

Z-3037-2024
Recall number
Z-3037-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ0209716K , Lot Number 19ABR348 ; DYNJ0209716K , Lot Number 19CBC954 ; DYNJ0209716K , Lot Number 19CBY010 ; DYNJ0209716K , Lot Number 19PBC426 ; DYNJ0233004D , Lot Number 19BKC696 ; DYNJ0233004D , Lot Number 19EKB353 ; DYNJ0233004D , Lot Number 19EKD788 ; DYNJ0233004D , Lot Number 19IKB771 ; DYNJ0233004D , Lot Number 19JKB511 ; DYNJ0233004D , Lot Number 20AKC285 ; DYNJ0233004D , Lot Number 20CKA142 ; DYNJ0233004D , Lot Number 20EKA118 ; DYNJ0233004D , Lot Number 20EKB817 ; DYNJ0233004D , Lot Number 20FKA173 ; DYNJ0233004D , Lot Number 20HKC130 ; DYNJ0233004D , Lot Number 20LKA046 ; DYNJ0373061J , Lot Number 21IBN110 ; DYNJ0373061J , Lot Number 21IBN112 ; DYNJ0373061J , Lot Number 21IBW039 ; DYNJ0373061J , Lot Number 21JBQ249 ; DYNJ0373061J , Lot Number 21JBQ254 ; DYNJ0373061J , Lot Number 22CBE209 ; DYNJ0373061J , Lot Number 22DBD601 ; DYNJ0373061J , Lot Number 22DBE605 ; DYNJ0373061J , Lot Number 22JBF498 ; DYNJ0373061J , Lot Number 22KBK232 ; DYNJ0373061J , Lot Number 22KBK234 ; DYNJ0373061J , Lot Number 23ABU873 ; DYNJ0373061J , Lot Number 23CBL581 ; DYNJ0373061J , Lot Number 23EBI151 ; DYNJ0373061J , Lot Number 23GBK887 ; DYNJ0373061J , Lot Number 23IBS102 ; DYNJ0373061J , Lot Number 23JBR178 ; DYNJ0373061J , Lot Number 23KBC777 ; DYNJ0373061J , Lot Number 23LBH622 ; DYNJ0373061J , Lot Number 24ABR895 ; DYNJ0373061J , Lot Number 21FBG073 ; DYNJ0373061J , Lot Number 19AKA894 ; DYNJ0373061J , Lot Number 19BKA317 ; DYNJ0373061J , Lot Number 19CKC943 ; DYNJ0373061J , Lot Number 19FKA631 ; DYNJ0373061J , Lot Number 19HKB486 ; DYNJ0373061J , Lot Number 19IKC235 ; DYNJ0373061J , Lot Number 19LKA527 ; DYNJ0373061J , Lot Number 20BKB137 ; DYNJ0373061J , Lot Number 20EKA922 ; DYNJ0373061J , Lot Number 20JKA379 ; DYNJ0373061J , Lot Number 20LKA412 ; DYNJ0406118K , Lot Number 19ABK827 ; DYNJ0406118K , Lot Number 19CBO755 ; DYNJ0406118K , Lot Number 19EBB219 ; DYNJ0406118K , Lot Number 19GBE862 ; DYNJ0406118K , Lot Number 19JBL458 ; DYNJ0618509F , Lot Number 19ABW463 ; DYNJ0618509F , Lot Number 19CBR084 ; DYNJ0618509F , Lot Number 19EBJ402 ; DYNJ0618509F , Lot Number 19FBV871 ; DYNJ0618509F , Lot Number 19HBL361 ; DYNJ0618509F , Lot Number 19VBE228 ; DYNJ0618509F , Lot Number 20ABL413 ; DYNJ0618509F , Lot Number 20DBF289 ; DYNJ0618509F , Lot Number 20EBF874 ; DYNJ22911I , Lot Number 19BBI118 ; DYNJ22911I , Lot Number 19DBF595 ; DYNJ22911I , Lot Number 19GBW575 ; DYNJ22911I , Lot Number 19VBD554 ; DYNJ22911I , Lot Number 19LBP763 ; DYNJ22911I , Lot Number 20BBA910 ; DYNJ22911I , Lot Number 20BBK239 ; DYNJ22911I , Lot Number 20DBG377 ; DYNJ22911I , Lot Number 20EBC409 ; DYNJ22911I , Lot Number 20EBL410 ; DYNJ36314J , Lot Number 19BKA012 ; DYNJ36314J , Lot Number 19CKC650 ; DYNJ36314J , Lot Number 19EKA892 ; DYNJ36314J , Lot Number 19FKB857 ; DYNJ36314J , Lot Number 19HKD378 ; DYNJ37265F , Lot Number 19BBB695 ; DYNJ37265F , Lot Number 19CBI334 ; DYNJ37265F , Lot Number 19PBA263 ; DYNJ37265F , Lot Number 19EBN075 ; DYNJ37265F , Lot Number 19EBW325 ; DYNJ37265F , Lot Number 19RBB628 ; DYNJ37265F , Lot Number 19SBH191 ; DYNJ39689D , Lot Number 19ABT447 ; DYNJ39689D , Lot Number 19CBB349 ; DYNJ39689D , Lot Number 19CBM013 ; DYNJ39689D , Lot Number 19EBJ211 ; DYNJ39689D , Lot Number 19EBS012 ; DYNJ39689D , Lot Number 19HBB315 ; DYNJ39689D , Lot Number 19HBC691 ; DYNJ42065B , Lot Number 19BLA452 ; DYNJ42065B , Lot Number 19CLA566 ; DYNJ42065B , Lot Number 19DLA032 ; DYNJ42065B , Lot Number 19ELA024 ; DYNJ42065B , Lot Number 19FLA415 ; DYNJ42065B , Lot Number 19GLA333 ; DYNJ42065B , Lot Number 19LLA035 ; DYNJ42065B , Lot Number 19LLA221 ; DYNJ42065B , Lot Number 20BLA480 ; DYNJ42065B , Lot Number 20CLA184 ; DYNJ42065B , Lot Number 20FLA227 ; DYNJ42065B , Lot Number 20HLA895 ; DYNJ42065B , Lot Number 20JLA332 ; DYNJ42065B , Lot Number 20KLA470 ; DYNJ42065B , Lot Number 21FLA048 ; DYNJ42065B , Lot Number 21HLA557 ; DYNJ42065B , Lot Number 21HLA596 ; DYNJ42065B , Lot Number 21ILA454 ; DYNJ42065B , Lot Number 21JLA621 ; DYNJ42065B , Lot Number 22CLB117 ; DYNJ42065B , Lot Number 22GLA668 ; DYNJ42065B , Lot Number 22HLA004 ; DYNJ42065B , Lot Number 22JLA859 ; DYNJ42065B , Lot Number 23ELA629 ; DYNJ42065B , Lot Number 23FLA014 ; DYNJ42065B , Lot Number 23GLA520 ; DYNJ42065B , Lot Number 23HLA874 ; DYNJ42065B , Lot Number 24ALA034 ; DYNJ42065B , Lot Number 24CLA157 ; DYNJ43815C , Lot Number 19BBG871 ; DYNJ43815C , Lot Number 19CBQ327 ; DYNJ43815C , Lot Number 19EBA243 ; DYNJ43815C , Lot Number 19EBR588 ; DYNJ43815C , Lot Number 19GBH867 ; DYNJ43815C , Lot Number 19HBM088 ; DYNJ50738, Lot Number 19JLA127 ; DYNJ50738, Lot Number 19LLA497 ; DYNJ50738, Lot Number 20JLA381 ; DYNJ50738, Lot Number 21BLA326 ; DYNJ50738, Lot Number 21ILA351 ; DYNJ50738, Lot Number 21LLA413 ; DYNJ50738, Lot Number 23DLB052 ; DYNJ50738, Lot Number 23FLA753 ; DYNJ50738, Lot Number 24ALA045 ; DYNJ903538C, Lot Number 19IBE935 ; DYNJ903538C, Lot Number 19IBM081 ; DYNJ903538C, Lot Number 19JBU933 ; DYNJ903538C, Lot Number 20ABQ212 ; DYNJ903545C, Lot Number 19FBB458 ; DYNJ903545C, Lot Number 19IBA011 ; DYNJ903545C, Lot Number 19LBJ430 ; DYNJ903545C, Lot Number 20ABT998 ; DYNJ903545C, Lot Number 20DBL053 ; DYNJ903545C, Lot Number 20HBE586 ; DYNJ903545C, Lot Number 21ABL355 ; DYNJ903545C, Lot Number 21BBG940 ; DYNJCD0114 , Lot Number 21EMF296 ; DYNJCD0114 , Lot Number 22CMA466

Distribution pattern

Worldwide distribution.

device · product 58 of 81

Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ; 6) NEW LIFE PACK , Pack Number DYNJ69208B ; 7) RADIOLOGY PACK, Pack Number DYNJ69603; 8)AMBULATORY MINI PACK, Pack Number DYNJ82579; 9) NURSING SKILLS, Pack Number EDUC1023

Z-3038-2024
Recall number
Z-3038-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYKA1225B, Lot Number 21GMC515 ; DYNDA3019, Lot Number 23BBO847 ; DYNDA3019, Lot Number 23GBI102 ; DYNDA3019, Lot Number 23HBO766 ; DYNJ16121O , Lot Number 23BBR366 ; DYNJ16121O , Lot Number 23DBR520 ; DYNJ16121O , Lot Number 23FBU745 ; DYNJ16121O , Lot Number 23GBV975 ; DYNJ16121O , Lot Number 23IBR246 ; DYNJ16121O , Lot Number 23LBR806 ; DYNJ16121O , Lot Number 24ABR196 ; DYNJ59783C , Lot Number 21KMF298 ; DYNJ59783C , Lot Number 23FMC164 ; DYNJ69208A , Lot Number 22KBV360 ; DYNJ69208A , Lot Number 23FBE076 ; DYNJ69208B , Lot Number 23IBN578 ; DYNJ69208B , Lot Number 23KBR836 ; DYNJ69603, Lot Number 21HMG219 ; DYNJ69603, Lot Number 21JMI295 ; DYNJ69603, Lot Number 22BMB206 ; DYNJ69603, Lot Number 22GMB031 ; DYNJ69603, Lot Number 22HMA445 ; DYNJ69603, Lot Number 22HMF745 ; DYNJ69603, Lot Number 22IME788 ; DYNJ69603, Lot Number 22JME874 ; DYNJ69603, Lot Number 23EMD691 ; DYNJ69603, Lot Number 23FMA290 ; DYNJ69603, Lot Number 23FMH511 ; DYNJ82579, Lot Number 23LBO804; DYNJ82579, Lot Number 23KBO218; DYNJ82579, Lot Number 23IBM199; DYNJ82579, Lot Number 23GBQ788; DYNJ82579, Lot Number 23EBT027; DYNJ82579, Lot Number 23EBC375; DYNJ82579, Lot Number 23CBP897; DYNJ82579, Lot Number 23BBG331; DYNJ82579, Lot Number 22LBH343; DYNJ82579, Lot Number 22HBQ045; EDUC1023 , Lot Number 22HDA683 ; EDUC1023 , Lot Number 22HDA854

Distribution pattern

Worldwide distribution.

device · product 59 of 81

Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657

Z-3039-2024
Recall number
Z-3039-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYK1002355X3, Lot Number 21JFA080; DYNJ84657, Lot Number 23GBD229

Distribution pattern

Worldwide distribution.

device · product 60 of 81

Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794; 6) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794H ; 7) CHEST TUBE INSERTION PACK , Pack Number DYNJ04474F ; 8) DRAINAGE FOR GRAPEVINE PACK , Pack Number DYNJ66222B ; 9) DRAINAGE PACK , Pack Number DYNJ67988A ; 10) CHEST/BREAST-LF , Pack Number DYNJ83950; 11) IR DRAIN PACK , Pack Number DYNJ85264; 12) INCISION AND DRAINAGE , Pack Number DYNJ904606C; 13) I&D TRAY, Pack Number MNS15250

Z-3040-2024
Recall number
Z-3040-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CHT2120, Lot Number 23DLA374 ; CHT2120, Lot Number 23ELA871 ; CHT2120, Lot Number 23FLA655 ; DYNDA2475, Lot Number 22IMA813 ; DYNDA2941A , Lot Number 23BMB940 ; DYNDA2941A , Lot Number 23FMF503 ; DYNDA2998, Lot Number 22KBB005 ; DYNDA2998, Lot Number 23BBD525 ; DYNDH1794, Lot Number 22LBM374 ; DYNDH1794, Lot Number 23EBL615 ; DYNDH1794, Lot Number 23LMF847 ; DYNDH1794H , Lot Number 23LMF847 ; DYNDH1794H , Lot Number 22LBM374 ; DYNDH1794H , Lot Number 23EBL615 ; DYNJ04474F , Lot Number 22JLA750 ; DYNJ04474F , Lot Number 23BLA545 ; DYNJ04474F , Lot Number 23FLA171 ; DYNJ66222B , Lot Number 24ALA413 ; DYNJ66222B , Lot Number 24ALA509 ; DYNJ66222B , Lot Number 24CLA156 ; DYNJ67988A , Lot Number 22JMG867 ; DYNJ67988A , Lot Number 22LMI605 ; DYNJ67988A , Lot Number 23AMJ359 ; DYNJ67988A , Lot Number 23DMG616 ; DYNJ67988A , Lot Number 23EMI610 ; DYNJ67988A , Lot Number 23GMB085 ; DYNJ67988A , Lot Number 23IMH819 ; DYNJ67988A , Lot Number 23KMF739 ; DYNJ83950, Lot Number 23CBG610 ; DYNJ83950, Lot Number 23FBF248 ; DYNJ83950, Lot Number 23LBR075 ; DYNJ85264, Lot Number 23KBE782 ; DYNJ904606C, Lot Number 23HBP402 ; DYNJ904606C, Lot Number 23IBS124 ; DYNJ904606C, Lot Number 23JBN042 ; DYNJ904606C, Lot Number 23KBW145 ; MNS15250 , Lot Number 24AMC318

Distribution pattern

Worldwide distribution.

device · product 61 of 81

Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack Number DYNDH1113; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) BIOPSY TRAY, Pack Number DYNDH1137C; 8) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 9) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 10) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1275; 11) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 12) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 13) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321; 15) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324B; 16) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 17) LUMBAR TRAY, Pack Number DYNDH1500; 18) TRAY SAFETY LUMBAR PUNCTURE 18GX3.5, Pack Number DYNDH1538; 19) TRAY SAFETY LUMBAR PUNCTURE 20GX3.5, Pack Number DYNDH1539; 20) LUMBAR TRAY, Pack Number DYNDH1540; 21) LUMBAR TRAY, Pack Number DYNDH1540A; 22) BIOPSY PACK, Pack Number DYNDH1556B; 23) BIOPSY KIT, Pack Number DYNDH1570; 24) MYELOGRAM TRAY, Pack Number DYNDH1574; 25) BIOPSY BASIC PACK, Pack Number DYNDH1588; 26) BIOPSY TRAY, Pack Number DYNDH1693; 27) BIOPSY TRAY, Pack Number DYNDH1693A; 28) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1698; 29) BIOPSY PACK, Pack Number DYNDL1462B; 30) LACERATION TRAY, Pack Number DYNDL1774A; 31) LACERATION TRAY, Pack Number DYNDL1887; 32) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 33) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B; 34) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 35) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 36) MYELOGRAM TRAY W/WATER SOLUBLE, Pack Number DYNJTS04035; 37) LUMBAR TRAY, Pack Number DYNJTS0422; 38) MYELOGRAM TRAY, Pack Number DYNJTS0514; 39) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS07025; 40) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 41) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4302; 42) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 43) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 44) CENTRAL LINE INSERTION KIT W/16CM CATH, Pack Number ECVC7440A; 45) OB DELIVERY TRAY, Pack Number MNS10875; 46) OB DELIVERY TRAY, Pack Number MNS10875A; 47) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 48) BIOPSY TRAY, Pack Number P151659; 49) ARTHROGRAM PACK, Pack Number P241108; 50) ARTHROGRAM TRAY, Pack Number SPEC0004C; 51) RADIOLOGY PACK-LF, Pack Number SPEC0127; 52) ARTHROGRAM TRAY, Pack Number SPEC0143A; 53) BIOPSY TRAY, Pack Number SPEC0148; 54) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 55) LUMBAR TRAY, Pack Number SPEC0177; 56) DR COPPEL FACET TRAY, Pack Number SPEC0178A; 57) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 58) LUMBAR TRAY, Pack Number SPEC0197D; 59) ARTHROGRAM TRAY, Pack Number SPEC0221A; 60) ARTHROGRAM TRAY, Pack Number SPEC0232; 61) 22G FACET TRAY, Pack Number SPEC0265A; 62) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289; 63) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 64) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 65) BIOPSY TRAY-LF, Pack Number SPEC4380; 66) LACERATION TRAY, Pack Number SUT18080; 67) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 68) UMBILICAL VESSEL TRAY, Pack Number UVT1100A

Z-3041-2024
Recall number
Z-3041-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDA2063, Lot Number 2021111250; DYNDA2080, Lot Number 2019052290; DYNDA2495, Lot Number 2021040550; DYNDA2497, Lot Number 2022042650; DYNDH1113, Lot Number 2020022450; DYNDH1134, Lot Number 2021022250; DYNDH1137C, Lot Number 2021081990; DYNDH1257, Lot Number 2019120650; DYNDH1257, Lot Number 2020060550; DYNDH1257, Lot Number 2021041550; DYNDH1270, Lot Number 2019040490; DYNDH1275, Lot Number 2019022090; DYNDH1275, Lot Number 2019050990; DYNDH1275, Lot Number 2019070390; DYNDH1275, Lot Number 2019081990; DYNDH1297, Lot Number 2022041250; DYNDH1300, Lot Number 2020060550; DYNDH1300, Lot Number 2022041250; DYNDH1319, Lot Number 2020012750; DYNDH1321, Lot Number 2019032290; DYNDH1324B, Lot Number 2022032950; DYNDH1359, Lot Number 2019040490; DYNDH1500, Lot Number 2020012750; DYNDH1500, Lot Number 2022031050; DYNDH1500, Lot Number 2022032950; DYNDH1538, Lot Number 2020070850; DYNDH1539, Lot Number 2020070850; DYNDH1539, Lot Number 2022042850; DYNDH1540, Lot Number 2020080750; DYNDH1540, Lot Number 2020100250; DYNDH1540A, Lot Number 2020110950; DYNDH1540A, Lot Number 2021042250; DYNDH1540A, Lot Number 2021070750; DYNDH1540A, Lot Number 2021091850; DYNDH1540A, Lot Number 2023050190; DYNDH1540A, Lot Number 2023061390; DYNDH1556B, Lot Number 2022031050; DYNDH1570, Lot Number 2021041350; DYNDH1570, Lot Number 2022032450; DYNDH1574, Lot Number 2022031450; DYNDH1588, Lot Number 2021021750; DYNDH1693, Lot Number 2021122050; DYNDH1693A, Lot Number 2022011150; DYNDH1698, Lot Number 2022022550; DYNDH1698, Lot Number 2022031650; DYNDH1698, Lot Number 2022040550; DYNDH1698, Lot Number 2022052550; DYNDH1698, Lot Number 2022060850; DYNDL1462B, Lot Number 2022042650; DYNDL1462B, Lot Number 2022050450; DYNDL1774A, Lot Number 2019040490; DYNDL1887, Lot Number 2019101890; DYNJ05162, Lot Number 2020022450; DYNJRA0313B, Lot Number 2019040490; DYNJRA0313B, Lot Number 2019053190; DYNJRA0313B, Lot Number 2019102390; DYNJTS0018A, Lot Number 2020071050; DYNJTS0214, Lot Number 2021022250; DYNJTS04035, Lot Number 2020071050; DYNJTS0422, Lot Number 2019122750; DYNJTS0422, Lot Number 2020012350; DYNJTS0422, Lot Number 2020040850; DYNJTS0422, Lot Number 2020050850; DYNJTS0422, Lot Number 2020062550; DYNJTS0422, Lot Number 2020072350; DYNJTS0514, Lot Number 2022022250; DYNJTS07025, Lot Number 2020110450; DYNJTS07025, Lot Number 2021022250; DYNJTS07025, Lot Number 2021041550; DYNJTS07025, Lot Number 2021052450; DYNJTS07025, Lot Number 2021091850; DYNJTS07025, Lot Number 2022011150; DYNJTS07025, Lot Number 2022020750; DYNJTS07025, Lot Number 2022040650; DYNJTS4301, Lot Number 2020060550; DYNJTS4301, Lot Number 2020060550; DYNJTS4301, Lot Number 2020072250; DYNJTS4301, Lot Number 2020072250; DYNJTS4301, Lot Number 2020081950; DYNJTS4301, Lot Number 2020120450; DYNJTS4301, Lot Number 2021021750; DYNJTS4301, Lot Number 2021040550; DYNJTS4301, Lot Number 2021050250; DYNJTS4301, Lot Number 2021082550; DYNJTS4301, Lot Number 2021102250; DYNJTS4301, Lot Number 2021112250; DYNJTS4301, Lot Number 2021121750; DYNJTS4301, Lot Number 2021121750; DYNJTS4301, Lot Number 2021122050; DYNJTS4301, Lot Number 2021122050; DYNJTS4301, Lot Number 2022020350; DYNJTS4301, Lot Number 2022020350; DYNJTS4301, Lot Number 2022021850; DYNJTS4301, Lot Number 2022030250; DYNJTS4301, Lot Number 2022031450; DYNJTS4301, Lot Number 2022032450; DYNJTS4301, Lot Number 2022033050; DYNJTS4301, Lot Number 2022041250; DYNJTS4301, Lot Number 2022041350; DYNJTS4301, Lot Number 2022041350; DYNJTS4301, Lot Number 2022042650; DYNJTS4301, Lot Number 2022042550; DYNJTS4301, Lot Number 2022050450; DYNJTS4301, Lot Number 2022051850; DYNJTS4302, Lot Number 2020060850; DYNJTS4302, Lot Number 2020072250; DYNJTS4302, Lot Number 2020090250; DYNJTS4302, Lot Number 2020110250; DYNJTS4302, Lot Number 2021020950; DYNJTS4302, Lot Number 2021041350; DYNJTS4302, Lot Number 2021060150; DYNJTS4302, Lot Number 2021081950; DYNJTS4302, Lot Number 2021081950; DYNJTS4302, Lot Number 2022020250; DYNJTS4302, Lot Number 2022030650; DYNJTS4302, Lot Number 2022031450; DYNJTS4302, Lot Number 2022040650; DYNJTS4302, Lot Number 2022040650; DYNJTS4306, Lot Number 2019120650; DYNJTS4306, Lot Number 2020022450; DYNJTS4306, Lot Number 2020042250; DYNJTS4306, Lot Number 2020061150; DYNJTS4306, Lot Number 2020071050; DYNJTS4306, Lot Number 2020090250; DYNJTS4306, Lot Number 2020093050; DYNJTS4306, Lot Number 2021011950; DYNJTS4306, Lot Number 2021051350; DYNJTS4306, Lot Number 2021080650; DYNJTS4306, Lot Number 2021082750; DYNJTS4306, Lot Number 2021091850; DYNJTS4306, Lot Number 2022022250; DYNJTS8100, Lot Number 2019111450; DYNJTS8100, Lot Number 2020081850; DYNJTS8100, Lot Number 2021031750; DYNJTS8100, Lot Number 2021060250; DYNJTS8100, Lot Number 2021072750; DYNJTS8100, Lot Number 2021111250; DYNJTS8100, Lot Number 2022041850; ECVC7440A, Lot Number 2022031450; MNS10875, Lot Number 2019040890; MNS10875A, Lot Number 2021081990; MNS4815, Lot Number 2023050190; P151659, Lot Number 2019102390; P241108, Lot Number 2020072250; P241108, Lot Number 2021082550; P241108, Lot Number 2021111250; SPEC0004C, Lot Number 2019053190; SPEC0127, Lot Number 2019111880; SPEC0143A, Lot Number 2020100250; SPEC0143A, Lot Number 2021082550; SPEC0143A, Lot Number 2022011150; SPEC0148, Lot Number 2022032950; SPEC0149, Lot Number 2020100250; SPEC0177, Lot Number 2018121090; SPEC0177, Lot Number 2019040890; SPEC0177, Lot Number 2019052290; SPEC0177, Lot Number 2019091190; SPEC0177, Lot Number 2019101890; SPEC0177, Lot Number 2020021390; SPEC0177, Lot Number 2021081990; SPEC0177, Lot Number 2021091690; SPEC0178A, Lot Number 2019040890; SPEC0178A, Lot Number 2019050990; SPEC0196B, Lot Number 2019102390; SPEC0197D, Lot Number 2019111880; SPEC0197D, Lot Number 2020060180; SPEC0221A, Lot Number 2020090250; SPEC0221A, Lot Number 2022033050; SPEC0232, Lot Number 2021041550; SPEC0265A, Lot Number 2019101890; SPEC0289, Lot Number 2019050990; SPEC0289, Lot Number 2019071690; SPEC0289, Lot Number 2019092390; SPEC0289, Lot Number 2019121790; SPEC0300B, Lot Number 2022033050; SPEC0400, Lot Number 2020072250; SPEC4380, Lot Number 2021041550; SUT18080, Lot Number 2020100250; SUT18080, Lot Number 2022011150; SUT20455, Lot Number 2019040490; UVT1100A, Lot Number 2022020250; UVT1100A, Lot Number 2022022250

Distribution pattern

Worldwide distribution.

device · product 62 of 81

Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS780056L ; 6) SHUNT CDS-LF, Pack Number CDS780103K ; 7) NEURO CDS , Pack Number CDS780108T ; 8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ; 9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ; 10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ; 11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ; 12) NEURO CDS , Pack Number CDS780162AA; 13) NEURO CDS , Pack Number CDS780162AB; 14) NEURO CDS , Pack Number CDS780162AC; 15) NEURO CDS , Pack Number CDS780162AD; 16) NEURO CDS , Pack Number CDS780162X ; 17) NEURO CDS , Pack Number CDS780162Y ; 18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ; 19) BASIC NEURO PACK, Pack Number CDS780202L ; 20) BASIC NEURO PACK, Pack Number CDS780202O ; 21) BASIC NEURO PACK, Pack Number CDS780202P ; 22) BASIC NEURO PACK, Pack Number CDS780202Q ; 23) BASIC NEURO PACK, Pack Number CDS780202R ; 24) NEURO-LAMI CDS, Pack Number CDS780208D ; 25) NEURO-LAMI CDS, Pack Number CDS780208F ; 26) NEURO CDS, Pack Number CDS780230K; 27) NEURO CDS , Pack Number CDS780230K ; 28) VP SHUNT, Pack Number CDS840193U ; 29) NEURO CDS-LF, Pack Number CDS980853N ; 30) VP SHUNT CDS-LF , Pack Number CDS981084K ; 31) VP SHUNT CDS-LF , Pack Number CDS981084L ; 32) VP SHUNT CDS-LF , Pack Number CDS981084M ; 33) NEURO KIT , Pack Number CDS981327N ; 34) NEURO KIT , Pack Number CDS981327O ; 35) NEURO KIT , Pack Number CDS981327P ; 36) NERVE STIMULATOR, Pack Number CDS981579N ; 37) NEURO MINOR CDS , Pack Number CDS981708K ; 38) VP SHUNT CDS, Pack Number CDS981740F ; 39) VP SHUNT CDS, Pack Number CDS981740J ; 40) VP SHUNT CDS, Pack Number CDS981740K ; 41) VP SHUNT CDS, Pack Number CDS981740KH; 42) MICRO DISC CDS, Pack Number CDS981886P ; 43) MICRO DISC CDS, Pack Number CDS981886R ; 44) MICRO DISC CDS, Pack Number CDS981886S ; 45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ; 46) NEURO CDS , Pack Number CDS982603L ; 47) NEURO CDS , Pack Number CDS982603M ; 48) NEURO CDS , Pack Number CDS982603N ; 49) NEURO SPINE CDS , Pack Number CDS982683Q ; 50) MAJOR NEURO , Pack Number CDS982704K ; 51) MAJOR NEURO , Pack Number CDS982704M ; 52) MAJOR NEURO , Pack Number CDS982704N ; 53) NEURO CDS CHS-LF, Pack Number CDS982745D ; 54) NEURO CDS CHS-LF, Pack Number CDS982745F ; 55) NEURO CDS CHS-LF, Pack Number CDS982745G ; 56) AV SHUNT CDS, Pack Number CDS983098D ; 57) AV SHUNT CDS, Pack Number CDS983098F ; 58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ; 59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ; 60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ; 61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ; 62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ; 63) VP SHUNT, Pack Number CDS983366J ; 64) VP SHUNT, Pack Number CDS983366M ; 65) VP SHUNT, Pack Number CDS983366N ; 66) VP SHUNT, Pack Number CDS983366P ; 67) NEURO CDS-LF, Pack Number CDS983383F ; 68) NEURO CDS-LF, Pack Number CDS983383G ; 69) NEURO CDS-LF, Pack Number CDS983383I ; 70) NEURO CDS-LF, Pack Number CDS983383J ; 71) AV SHUNT CDS, Pack Number CDS983792C ; 72) AV SHUNT CDS, Pack Number CDS983792D ; 73) ANTERIOR NEURO CDS, Pack Number CDS983882C ; 74) ANTERIOR NEURO CDS, Pack Number CDS983882D ; 75) POSTERIOR NEURO CDS , Pack Number CDS983885C ; 76) POSTERIOR NEURO CDS , Pack Number CDS983885D ; 77) POSTERIOR NEURO CDS , Pack Number CDS983885F ; 78) NEURO CDS , Pack Number CDS983981D ; 79) NEURO CDS , Pack Number CDS983981F ; 80) NEURO CDS , Pack Number CDS983981I ; 81) NEURO CDS , Pack Number CDS983981J ; 82) NEURO CDS , Pack Number CDS983981K ; 83) NEURO CDS , Pack Number CDS983981L ; 84) CRANI NEURO CDS , Pack Number CDS984172F ; 85) PUH NEURO EEA CDS , Pack Number CDS984297G ; 86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ; 87) ME

Z-3042-2024
Recall number
Z-3042-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

00-401327AA, Lot Number 20AMA256 ; 00-401327AA, Lot Number 20AMC142 ; 00-401327AA, Lot Number 20BMB258 ; 00-401327AA, Lot Number 20DMB109 ; 00-401327AA, Lot Number 20GMB772 ; 00-401327AA, Lot Number 20HMC035 ; 00-401327AA, Lot Number 20JMA910 ; 00-401327AA, Lot Number 20JMB656 ; 00-401327AA, Lot Number 21CMA167 ; 00-401327AA, Lot Number 21EMB860 ; 00-401327AA, Lot Number 21FMC472 ; 00-401327AA, Lot Number 21GMF286 ; 00-401327AA, Lot Number 21HME693 ; 00-401327AA, Lot Number 21IMC842 ; 00-401327AA, Lot Number 21KMB315 ; 00-401594R , Lot Number 19LDA473 ; 00-401594R , Lot Number 20ADB972 ; 00-401594R , Lot Number 20CDC521 ; 00-401594R , Lot Number 20EDB836 ; 00-401594R , Lot Number 20HDA321 ; 00-401594R , Lot Number 21CDB556 ; 00-401594R , Lot Number 21EDA344 ; 00-401808S , Lot Number 21GBR684 ; 00-401808S , Lot Number 21IBB505 ; 00-401808S , Lot Number 21JBD593 ; 00-401808S , Lot Number 21JBD594 ; 00-401808S , Lot Number 21JBD596 ; 00-401808S , Lot Number 22ABS576 ; 00-401808S , Lot Number 19ABL630 ; 00-401808S , Lot Number 22NBA002 ; 00-401808S , Lot Number 19BBJ217 ; 00-401808S , Lot Number 22OBB643 ; 00-401808S , Lot Number 19DBK655 ; 00-401808S , Lot Number 22FBO951 ; 00-401808S , Lot Number 19FBI621 ; 00-401808S , Lot Number 19FBV633 ; 00-401808S , Lot Number 22HBR194 ; 00-401808S , Lot Number 22IBG899 ; 00-401808S , Lot Number 19HBL271 ; 00-401808S , Lot Number 22JBH625 ; 00-401808S , Lot Number 19IBG849 ; 00-401808S , Lot Number 22KBP137 ; 00-401808S , Lot Number 19IBZ700 ; 00-401808S , Lot Number 22LBN374 ; 00-401808S , Lot Number 19VBC278 ; 00-401808S , Lot Number 19KBQ992 ; 00-401808S , Lot Number 23CBC166 ; 00-401808S , Lot Number 19LBK455 ; 00-401808S , Lot Number 23CBW993 ; 00-401808S , Lot Number 23EBE204 ; 00-401808S , Lot Number 23EBF240 ; 00-401808S , Lot Number 20CBH056 ; 00-401808S , Lot Number 23GBN716 ; 00-401808S , Lot Number 20CBY951 ; 00-401808S , Lot Number 23HBG573 ; 00-401808S , Lot Number 20FBB585 ; 00-401808S , Lot Number 20FBE238 ; 00-401808S , Lot Number 20FBF231 ; 00-401808S , Lot Number 23JBC088 ; 00-401808S , Lot Number 20GBJ388 ; 00-401808S , Lot Number 23KBM084 ; 00-401808S , Lot Number 20JBC354 ; 00-401808S , Lot Number 20LBD734 ; 00-401808S , Lot Number 21CBX182 ; CDS780056K , Lot Number 19BBQ112 ; CDS780056K , Lot Number 19FBQ838 ; CDS780056K , Lot Number 19HBN954 ; CDS780056K , Lot Number 19JBJ354 ; CDS780056K , Lot Number 19KBF418 ; CDS780056K , Lot Number 20BBF089 ; CDS780056K , Lot Number 20OBA309 ; CDS780056K , Lot Number 20DBL328 ; CDS780056K , Lot Number 20GBL494 ; CDS780056K , Lot Number 20GBV115 ; CDS780056K , Lot Number 20KBS804 ; CDS780056K , Lot Number 20WBI356 ; CDS780056K , Lot Number 21DBU610 ; CDS780056L , Lot Number 21IBV394 ; CDS780056L , Lot Number 21KBG946 ; CDS780103K , Lot Number 22OBI238 ; CDS780103K , Lot Number 22FBF458 ; CDS780103K , Lot Number 22HBF971 ; CDS780103K , Lot Number 22HBF972 ; CDS780103K , Lot Number 22IBQ334 ; CDS780103K , Lot Number 22JBR855 ; CDS780103K , Lot Number 22LBB223 ; CDS780103K , Lot Number 23BBD147 ; CDS780103K , Lot Number 23FBQ301 ; CDS780103K , Lot Number 23GBE098 ; CDS780103K , Lot Number 23GBT769 ; CDS780103K , Lot Number 23IBB510 ; CDS780103K , Lot Number 23JBG685 ; CDS780103K , Lot Number 23LBR311 ; CDS780103K , Lot Number 23LBV808 ; CDS780103K , Lot Number 24CBE995 ; CDS780108T , Lot Number 19DLA065 ; CDS780108T , Lot Number 19DLA501 ; CDS780108T , Lot Number 19DLA665 ; CDS780108T , Lot Number 19FLA394 ; CDS780108T , Lot Number 19GLA142 ; CDS780108T , Lot Number 19GLA202 ; CDS780108T , Lot Number 19GLA261 ; CDS780108T , Lot Number 19HLA111 ; CDS780108T , Lot Number 19HLA402 ; CDS780108T , Lot Number 19ILA293 ; CDS780108T , Lot Number 19JLA050 ; CDS780108T , Lot Number 19JLA667 ; CDS780108T , Lot Number 19KLA463 ; CDS780108T , Lot Number 20ALA303 ; CDS780108T , Lot Number 20BLA407 ; CDS780109M , Lot Number 19CBI751 ; CDS780109M , Lot Number 19CBR419 ; CDS780109N , Lot Number 19EBU235 ; CDS780109N , Lot Number 19FBO209 ; CDS780109N , Lot Number 19HBD224 ; CDS780109N , Lot Number 19JBT649 ; CDS780109N , Lot Number 19KBY989 ; CDS780109N , Lot Number 20ABT942 ; CDS780109N , Lot Number 20CBY395 ; CDS780109O , Lot Number 21HBM967 ; CDS780109O , Lot Number 21KBC808 ; CDS780109O , Lot Number 22BBC815 ; CDS780109O , Lot Number 22OBA987 ; CDS780109O , Lot Number 22EBE862 ; CDS780109O , Lot Number 22FBI951 ; CDS780109O , Lot Number 22GBK671 ; CDS780109O , Lot Number 22HBZ276 ; CDS780109O , Lot Number 22IBK666 ; CDS780109O , Lot Number 22KBD840 ; CDS780109O , Lot Number 23ABG956 ; CDS780109O , Lot Number 23CBO553 ; CDS780109O , Lot Number 23DBB223 ; CDS780109O , Lot Number 23EBP966 ; CDS780109O , Lot Number 23FBL915 ; CDS780109O , Lot Number 23HBL622 ; CDS780109O , Lot Number 23HBO324 ; CDS780109O , Lot Number 23IBO480 ; CDS780109O , Lot Number 20HBG092 ; CDS780109O , Lot Number 20HBT149 ; CDS780109O , Lot Number 20WBE680 ; CDS780109O , Lot Number 20LBP961 ; CDS780109O , Lot Number 21DBB965 ; CDS780109O , Lot Number 21DBN004 ; CDS780109O , Lot Number 21FBD640 ; CDS780119T , Lot Number 19DBE959 ; 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CDS983882C , Lot Number 20WBG081 ; CDS983882C , Lot Number 20WBH055 ; CDS983882D , Lot Number 21KBW920 ; CDS983882D , Lot Number 22DBC999 ; CDS983882D , Lot Number 22EBF941 ; CDS983882D , Lot Number 22IBS408 ; CDS983882D , Lot Number 22KBS879 ; CDS983882D , Lot Number 22KBU352 ; CDS983882D , Lot Number 23CBN738 ; CDS983882D , Lot Number 23CBU024 ; CDS983882D , Lot Number 23EBE364 ; CDS983882D , Lot Number 21DBO237 ; CDS983885C , Lot Number 19ABZ077 ; CDS983885C , Lot Number 19CBH298 ; CDS983885C , Lot Number 19CBI390 ; CDS983885C , Lot Number 19EBH562 ; CDS983885C , Lot Number 19EBW020 ; CDS983885C , Lot Number 19HBU754 ; CDS983885C , Lot Number 19VBD678 ; CDS983885C , Lot Number 19LBA424 ; CDS983885C , Lot Number 20ABX178 ; CDS983885C , Lot Number 20DBK597 ; CDS983885C , Lot Number 20EBC935 ; CDS983885C , Lot Number 20EBO728 ; CDS983885C , Lot Number 20GBB776 ; CDS983885C , Lot Number 20GBR728 ; CDS983885C , Lot Number 20HBU097 ; CDS983885C , Lot Number 20IBC372 ; CDS983885C , Lot Number 20JBA594 ; CDS983885C , Lot Number 20JBY179 ; CDS983885C , Lot Number 20KBY248 ; CDS983885C , Lot Number 21ABN772 ; CDS983885D , Lot Number 21HBQ028 ; CDS983885D , Lot Number 21IBU462 ; CDS983885D , Lot Number 21JBS156 ; CDS983885D , Lot Number 21JBX843 ; CDS983885D , Lot Number 22DBB159 ; CDS983885D , Lot Number 22EBF942 ; CDS983885D , Lot Number 22FBH437 ; CDS983885D , Lot Number 22FBX184 ; CDS983885D , Lot Number 22JBJ163 ; CDS983885D , Lot Number 22KBS655 ; CDS983885D , Lot Number 23ABL469 ; CDS983885D , Lot Number 23ABN789 ; CDS983885D , Lot Number 23CBI556 ; CDS983885D , Lot Number 23EBK997 ; CDS983885D , Lot Number 23EBU951 ; CDS983885D , Lot Number 23FBL260 ; CDS983885D , Lot Number 21CBT329 ; CDS983885D , Lot Number 21FBE881 ; CDS983885D , Lot Number 21FBE882 ; CDS983885D , Lot Number 22CLA523 ; CDS983885F , Lot Number 23KBU576 ; CDS983885F , Lot Number 23KBU834 ; CDS983885F , Lot Number 24ABB735 ; CDS983981D , Lot Number 19CBD170 ; CDS983981F , Lot Number 19DBP051 ; CDS983981F , Lot Number 19GBL027 ; CDS983981F , Lot Number 19JBT602 ; CDS983981F , Lot Number 19VBA665 ; CDS983981F , Lot Number 19VBC048 ; CDS983981I , Lot Number 20CBF484 ; CDS983981J , Lot Number 21GBE942 ; CDS983981J , Lot Number 21KBA430 ; CDS983981J , Lot Number 22ABZ200 ; CDS983981J , Lot Number 20LBI176 ; CDS983981J , Lot Number 20LBI813 ; CDS983981J , Lot Number 21BBF817 ; CDS983981J , Lot Number 21DBE159 ; CDS983981K , Lot Number 22EBG587 ; CDS983981K , Lot Number 22EBI118 ; CDS983981K , Lot Number 22HBM662 ; CDS983981K , Lot Number 22HBM664 ; CDS983981K , Lot Number 23ABG042 ; CDS983981L , Lot Number 23FBN470 ; CDS983981L , Lot Number 23GBK552 ; CDS983981L , Lot Number 23GBT893 ; CDS983981L , Lot Number 23IBT871 ; CDS983981L , Lot Number 23IBU172 ; CDS983981L , Lot Number 23KBN714 ; CDS983981L , Lot Number 23KBN899 ; CDS983981L , Lot Number 23KBW163 ; CDS984172F , Lot Number 21HBI256 ; CDS984172F , Lot Number 21IBI540 ; CDS984172F , Lot Number 21JBX767 ; CDS984172F , Lot Number 19PBB806 ; CDS984172F , Lot Number 20CBC244 ; CDS984172F , Lot Number 20GBC227 ; CDS984172F , Lot Number 20GBV765 ; CDS984172F , Lot Number 20HBI272 ; CDS984172F , Lot Number 20HBP058 ; CDS984172F , Lot Number 20HBU118 ; CDS984172F , Lot Number 20IBH561 ; CDS984172F , Lot Number 20JBR070 ; CDS984172F , Lot Number 21EBI482 ; CDS984172F , Lot Number 21EBK805 ; CDS984297G , Lot Number 21HBC361 ; CDS984297G , Lot Number 21HBC545 ; CDS984297G , Lot Number 21JBA878 ; CDS984297G , Lot Number 21JBF855 ; CDS984297G , Lot Number 22ABB092 ; CDS984297G , Lot Number 22BBJ452 ; CDS984297G , Lot Number 22BBJ453 ; CDS984297G , Lot Number 22GBI993 ; CDS984297G , Lot Number 22GBT350 ; CDS984297G , Lot Number 22IBR909 ; CDS984297G , Lot Number 22JBU173 ; CDS984297G , Lot Number 23ABO242 ; CDS984297G , Lot Number 23ABP041 ; CDS984297G , Lot Number 23BBU266 ; CDS984297G , Lot Number 20BBK648 ; CDS984297G , Lot Number 20DBK821 ; CDS984297G , Lot Number 20EBC094 ; CDS984297G , Lot Number 20GBC958 ; CDS984297G , Lot Number 20JBD419 ; CDS984297G , Lot Number 20JBI324 ; CDS984297G , Lot Number 20JBS770 ; CDS984297G , Lot Number 20LBM854 ; CDS984297G , Lot Number 21CBU578 ; CDS984297G , Lot Number 21DBP519 ; CDS984297G , Lot Number 21EBK875 ; CDS984323G , Lot Number 22IBS382 ; CDS984323G , Lot Number 22JBA696 ; CDS984323G , Lot Number 22KBW048 ; CDS984323G , Lot Number 22LBN379 ; CDS984323G , Lot Number 23BBI976 ; CDS984323G , Lot Number 23CBO815 ; CDS984323G , Lot Number 23DBF796 ; CDS984323G , Lot Number 23DBQ245 ; CDS984391S , Lot Number 19ABH340 ; CDS984391S , Lot Number 19ABH341 ; CDS984391S , Lot Number 19BBH126 ; CDS984391S , Lot Number 19BBU494 ; CDS984391S , Lot Number 19EBL578 ; CDS984391S , Lot Number 19SBF200 ; CDS984391S , Lot Number 19HBJ023 ; CDS984391S , Lot Number 19TBA428 ; CDS984391S , Lot Number 19IBX394 ; CDS984391S , Lot Number 19VBD038 ; CDS984391S , Lot Number 19KBR963 ; CDS984391S , Lot Number 20BBM841 ; CDS984391S , Lot Number 20CBL974 ; CDS984391T , Lot Number 21FBR344 ; CDS984391T , Lot Number 21IBJ265 ; CDS984391T , Lot Number 21JBO019 ; CDS984391T , Lot Number 21KBC810 ; CDS984391T , Lot Number 21LBU072 ; CDS984391T , Lot Number 22CBJ564 ; CDS984391T , Lot Number 22DBO564 ; CDS984391T , Lot Number 22FBD510 ; CDS984391T , Lot Number 22FBF407 ; CDS984391T , Lot Number 22FBF408 ; CDS984391T , Lot Number 22GBK211 ; CDS984391T , Lot Number 22HBX020 ; CDS984391T , Lot Number 22IBV462 ; CDS984391T , Lot Number 22KBS597 ; CDS984391T , Lot Number 23ABC403 ; CDS984391T , Lot Number 23BBS466 ; CDS984391T , Lot Number 20DBL050 ; CDS984391T , Lot Number 20GBQ745 ; CDS984391T , Lot Number 20JBP568 ; CDS984391T , Lot Number 20KBJ014 ; CDS984391T , Lot Number 20WBC643 ; CDS984391T , Lot Number 21CBT340 ; CDS984391T , Lot Number 21DBE161 ; CDS984496I , Lot Number 22DBS440 ; CDS984496I , Lot Number 22DBT289 ; CDS984496I , Lot Number 22FBW276 ; CDS984496I , Lot Number 22GBH595 ; CDS984564D , Lot Number 19CBA365 ; CDS984564F , Lot Number 19FBZ882 ; CDS984564F , Lot Number 20IBE932 ; CDS984651B , Lot Number 21JBJ734 ; CDS984651B , Lot Number 21JBV996 ; CDS984651B , Lot Number 19ABN004 ; CDS984651B , Lot Number 19BBF927 ; CDS984651B , Lot Number 19CBT725 ; CDS984651B , Lot Number 19EBC021 ; CDS984651B , Lot Number 19FBY917 ; CDS984651B , Lot Number 19GBD803 ; CDS984651B , Lot Number 19GBL163 ; CDS984651B , Lot Number 19KBK150 ; CDS984651B , Lot Number 19KBL058 ; CDS984651B , Lot Number 19LBX903 ; CDS984651B , Lot Number 20CBD248 ; CDS984651B , Lot Number 20CBW914 ; CDS984651B , Lot Number 20DBT443 ; CDS984651B , Lot Number 20IBE700 ; CDS984651B , Lot Number 20JBY194 ; CDS984651B , Lot Number 20XBC449 ; CDS984651B , Lot Number 21CBI427 ; CDS984651B , Lot Number 21CBL027 ; CDS985020D , Lot Number 19ABM830 ; CDS985020D , Lot Number 19BBI630 ; CDS985020D , Lot Number 19BBN779 ; CDS985020D , Lot Number 19BBT876 ; CDS985020D , Lot Number 19FBI190 ; CDS985020D , Lot Number 19HBD486 ; CDS985020D , Lot Number 19JBW484 ; CDS985020D , Lot Number 19KBL960 ; CDS985020D , Lot Number 20ABA050 ; CDS985246I , Lot Number 19AKB483 ; CDS985246I , Lot Number 19BKB687 ; CDS985246I , Lot Number 19CKD529 ; CDS985246I , Lot Number 19EKA113 ; CDS985246I , Lot Number 19FKC363 ; CDS985246I , Lot Number 19GKC687 ; CDS985246I , Lot Number 19JKA835 ; CDS985246J , Lot Number 21DME353 ; CDS985246J , Lot Number 21EME270 ; CDS985246J , Lot Number 21GME797 ; CDS985246J , Lot Number 21JMD713 ; CDS985246J , Lot Number 21JME074 ; CDS985246J , Lot Number 21KMH120 ; CDS985246J , Lot Number 21LMA027 ; CDS985246J , Lot Number 21LMF255 ; CDS985246J , Lot Number 22FMA322 ; CDS985246J , Lot Number 22GMB333 ; CDS985246J , Lot Number 22HMB295 ; CDS985246J , Lot Number 22IMB860 ; CDS985246J , Lot Number 22JMC335 ; CDS985246J , Lot Number 22KMH073 ; CDS985246J , Lot Number 22LMD214 ; CDS985246J , Lot Number 22LME459 ; CDS985246J , Lot Number 23BMA474 ; CDS985246J , Lot Number 23BMH175 ; CDS985246J , Lot Number 19LKA813 ; CDS985246J , Lot Number 20BKB661 ; CDS985246J , Lot Number 20CKA900 ; CDS985246J , Lot Number 20EKB756 ; CDS985246J , Lot Number 20HKB295 ; CDS985246J , Lot Number 20JKA916 ; CDS985246J , Lot Number 21CKA026 ; CDS985246K , Lot Number 23CMA813 ; CDS985246K , Lot Number 23CMF672 ; CDS985246K , Lot Number 23FMB824 ; CDS985246K , Lot Number 23FMF215 ; CDS985246K , Lot Number 23GMB417 ; CDS985246K , Lot Number 23IMF250 ; CDS985246K , Lot Number 23KMJ249 ; CDS985246K , Lot Number 23LMD819 ; CDS985289, Lot Number 21GBE846 ; CDS985289, Lot Number 21IBO741 ; CDS985289, Lot Number 21VBD126 ; CDS985289, Lot Number 19ABQ388 ; CDS985289, Lot Number 22CBS182 ; CDS985289, Lot Number 19CBM495 ; CDS985289, Lot Number 19DBJ999 ; CDS985289, Lot Number 22FBM615 ; CDS985289, Lot Number 19FBG059 ; CDS985289, Lot Number 22IBD861 ; CDS985289, Lot Number 22IBF823 ; CDS985289, Lot Number 22JBH363 ; CDS985289, Lot Number 19IBZ094 ; CDS985289, Lot Number 23ABD309 ; CDS985289, Lot Number 19LBH058 ; CDS985289, Lot Number 23CBW370 ; CDS985289, Lot Number 23FBC219 ; CDS985289, Lot Number 20CBW891 ; CDS985289, Lot Number 20FBU792 ; CDS985289, Lot Number 20IBD354 ; CDS985289, Lot Number 20LBG020 ; CDS985289, Lot Number 21CBE526 ; CDS985289A , Lot Number 23HBS924 ; CDS985289A , Lot Number 23LBB378 ; CDS985289A , Lot Number 23LBQ385 ; CDS985351, Lot Number 21GBH372 ; CDS985351, Lot Number 21GBH373 ; CDS985351, Lot Number 21GBK370 ; CDS985351, Lot Number 21KBA540 ; CDS985351, Lot Number 21KBV815 ; CDS985351, Lot Number 22ABW938 ; CDS985351, Lot Number 19ABS413 ; CDS985351, Lot Number 19BBR809 ; CDS985351, Lot Number 19CBO109 ; CDS985351, Lot Number 22DBG801 ; CDS985351, Lot Number 22FBE892 ; CDS985351, Lot Number 19EBU832 ; CDS985351, Lot Number 22FBV571 ; CDS985351, Lot Number 22GBT670 ; CDS985351, Lot Number 19GBE547 ; CDS985351, Lot Number 19TBD981 ; CDS985351, Lot Number 22LBB561 ; CDS985351, Lot Number 19JBX089 ; CDS985351, Lot Number 19LBI223 ; CDS985351, Lot Number 20BBQ482 ; CDS985351, Lot Number 20DBL304 ; CDS985351, Lot Number 20HBA708 ; CDS985351, Lot Number 20HBX532 ; CDS985351, Lot Number 20KBB647 ; CDS985351, Lot Number 21ABP687 ; CDS985351, Lot Number 21BBK099 ; CDS985386B , Lot Number 21FBN810 ; CDS985386B , Lot Number 21GBP372 ; CDS985386B , Lot Number 21JBP600 ; CDS985386B , Lot Number 21KBV749 ; CDS985386B , Lot Number 19BBG611 ; CDS985386B , Lot Number 22CBS299 ; CDS985386B , Lot Number 22OBM474 ; CDS985386B

Distribution pattern

Worldwide distribution.

device · product 63 of 81

Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453

Z-3043-2024
Recall number
Z-3043-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDH1453, Lot Number 20EBA949 ; DYNDH1453, Lot Number 21ABR125 ; DYNDH1453, Lot Number 22FMA793 ; DYNDH1453, Lot Number 22HMD391 ; DYNDH1453, Lot Number 22HMD549

Distribution pattern

Worldwide distribution.

device · product 64 of 81

Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CDS830039AK; 6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ; 7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ; 8) LABOR & DELIVERY, Pack Number CDS830054P ; 9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ; 10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ; 11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ; 12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ; 13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ; 14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ; 15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ; 16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ; 17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ; 18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ; 19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ; 20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ; 21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ; 22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ; 23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ; 24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ; 25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ; 26) DELIVERY CDS, Pack Number CDS830199K ; 27) DELIVERY CDS, Pack Number CDS981282O ; 28) OB PROCEDURE-LF , Pack Number CDS981335B ; 29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ; 30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ; 31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ; 32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ; 33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ; 34) VAGINAL MAJOR , Pack Number CDS982689O ; 35) VAGINAL MAJOR , Pack Number CDS982689P ; 36) VAGINAL MAJOR , Pack Number CDS982689Q ; 37) VAGINAL MAJOR , Pack Number CDS982689R ; 38) DELIVERY PROCEDURE, Pack Number CDS982761F ; 39) DELIVERY PROCEDURE, Pack Number CDS982761G ; 40) DELIVERY PROCEDURE, Pack Number CDS982761I ; 41) DELIVERY PROCEDURE, Pack Number CDS982761J ; 42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ; 43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ; 44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ; 45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ; 46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ; 47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ; 48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ; 49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ; 50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ; 51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959; 52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ; 53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ; 54) LABOR & DELIVERY CDS, Pack Number CDS983116C ; 55) LABOR & DELIVERY CDS, Pack Number CDS983116D ; 56) LABOR & DELIVERY CDS, Pack Number CDS983116F ; 57) LABOR & DELIVERY CDS, Pack Number CDS983116G ; 58) LABOR & DELIVERY CDS, Pack Number CDS983116I ; 59) MINOR VAGINAL CDS , Pack Number CDS983119B ; 60) VAGINAL MINOR , Pack Number CDS983268J ; 61) VAGINAL MINOR , Pack Number CDS983268L ; 62) GYN VAGINAL CDS , Pack Number CDS983528J ; 63) ACH MAJOR VAGINAL , Pack Number CDS983641F ; 64) ACH MAJOR VAGINAL , Pack Number CDS983641G ; 65) VAG HYST CDS, Pack Number CDS983697F ; 66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ; 67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ; 68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ; 69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ; 70) OB/GYN CDS, Pack Number CDS984173G ; 71) OB GYN, Pack Number CDS984173I ; 72) GROTH VAGINAL CDS , Pack Number CDS984201P ; 73) GROTH VAGINAL CDS , Pack Number CDS984201Q ; 74) GROTH VAGINAL CDS , Pack Number CDS984201R ; 75) GROTH VAGINAL CDS , Pack Number CDS984201U ; 76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ; 77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ; 78) VAGINAL DELIVERY CDS, Pack

Z-3044-2024
Recall number
Z-3044-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

AM185B , Lot Number 23BBS790 ; AM185B , Lot Number 23IBT868 ; AM185B , Lot Number 23JBW874 ; AM185B , Lot Number 24ABQ730 ; CDS830039AF, Lot Number 19GBO514 ; CDS830039AF, Lot Number 19HBS937 ; CDS830039AF, Lot Number 19JBM007 ; CDS830039AF, Lot Number 19VBF341 ; CDS830039AF, Lot Number 20ABQ286 ; CDS830039AF, Lot Number 20BBR820 ; CDS830039AF, Lot Number 20CBC115 ; CDS830039AF, Lot Number 20EBC561 ; CDS830039AF, Lot Number 20FBH160 ; CDS830039AF, Lot Number 20GBG417 ; CDS830039AF, Lot Number 20GBT038 ; CDS830039AF, Lot Number 20JBA496 ; CDS830039AF, Lot Number 20LBV774 ; CDS830039AF, Lot Number 21ABJ105 ; CDS830039AI, Lot Number 21HBA287 ; CDS830039AI, Lot Number 21HBG893 ; CDS830039AI, Lot Number 21IBJ983 ; CDS830039AI, Lot Number 21LBQ697 ; CDS830039AI, Lot Number 22ABA249 ; CDS830039AI, Lot Number 22CBY819 ; CDS830039AI, Lot Number 22OBB223 ; CDS830039AI, Lot Number 21CBQ656 ; CDS830039AI, Lot Number 21DBP447 ; CDS830039AI, Lot Number 21FBH085 ; CDS830039AJ, Lot Number 22DBI098 ; CDS830039AJ, Lot Number 22EBN206 ; CDS830039AJ, Lot Number 22FBC480 ; CDS830039AJ, Lot Number 22FBD486 ; CDS830039AJ, Lot Number 22FBT263 ; CDS830039AJ, Lot Number 22FBW862 ; CDS830039AK, Lot Number 22JBF161 ; CDS830039AK, Lot Number 22KBQ120 ; CDS830039AK, Lot Number 22LBC150 ; CDS830039AK, Lot Number 23ABF855 ; CDS830039AK, Lot Number 23CBH440 ; CDS830039AK, Lot Number 23FBK921 ; CDS830039AK, Lot Number 23FBK922 ; CDS830039AK, Lot Number 23GBA194 ; CDS830039AK, Lot Number 23HBO379 ; CDS830039AK, Lot Number 23IBE023 ; CDS830039AK, Lot Number 23JBL894 ; CDS830039AK, Lot Number 23KBB125 ; CDS830053G , Lot Number 21HBR110 ; CDS830053G , Lot Number 21IBJ984 ; CDS830053G , Lot Number 21KBT291 ; CDS830053G , Lot Number 21KBW772 ; CDS830053G , Lot Number 22BBK560 ; CDS830053G , Lot Number 19ABC405 ; CDS830053G , Lot Number 22BBQ057 ; CDS830053G , Lot Number 19ABX756 ; CDS830053G , Lot Number 22OBE801 ; CDS830053G , Lot Number 19CBI663 ; CDS830053G , Lot Number 22DBN943 ; CDS830053G , Lot Number 19EBC550 ; CDS830053G , Lot Number 22GBA870 ; CDS830053G , Lot Number 19FBN913 ; CDS830053G , Lot Number 19HBZ072 ; CDS830053G , Lot Number 19IBI894 ; CDS830053G , Lot Number 19IBP482 ; CDS830053G , Lot Number 19JBP810 ; CDS830053G , Lot Number 19LBL676 ; CDS830053G , Lot Number 20ABL825 ; CDS830053G , Lot Number 20CBV686 ; CDS830053G , Lot Number 20FBN246 ; CDS830053G , Lot Number 20GBP178 ; CDS830053G , Lot Number 20IBC356 ; CDS830053G , Lot Number 20IBG769 ; CDS830053G , Lot Number 20LBV829 ; CDS830053G , Lot Number 21ABM101 ; CDS830053G , Lot Number 21BBA375 ; CDS830053G , Lot Number 21CBA201 ; CDS830053G , Lot Number 21CBB711 ; CDS830053I , Lot Number 22GBB014 ; CDS830053I , Lot Number 22IBJ347 ; CDS830053I , Lot Number 22JBP418 ; CDS830053I , Lot Number 22KBF644 ; CDS830053I , Lot Number 22KBS025 ; CDS830053I , Lot Number 23BBA669 ; CDS830053I , Lot Number 23BBJ070 ; CDS830053I , Lot Number 23BBN831 ; CDS830053I , Lot Number 23EBD612 ; CDS830053I , Lot Number 23FBA344 ; CDS830053I , Lot Number 23GBD900 ; CDS830053I , Lot Number 23IBJ528 ; CDS830053I , Lot Number 23IBS206 ; CDS830053I , Lot Number 23JBO100 ; CDS830053I , Lot Number 23KBR822 ; CDS830053I , Lot Number 24ABB121 ; CDS830053I , Lot Number 24BBN779 ; CDS830054P , Lot Number 21JBO031 ; CDS830054P , Lot Number 21JBX762 ; CDS830116T , Lot Number 21EMB670 ; CDS830116T , Lot Number 21GMA024 ; CDS830116T , Lot Number 21JMB604 ; CDS830116T , Lot Number 21JMF853 ; CDS830116T , Lot Number 21JMH576 ; CDS830116T , Lot Number 21LMF690 ; CDS830116T , Lot Number 22DMB054 ; CDS830116T , Lot Number 22DMI608 ; CDS830116T , Lot Number 22GMA496 ; CDS830116T , Lot Number 22HMG373 ; CDS830116T , Lot Number 22IME198 ; CDS830116T , Lot Number 22JMD253 ; CDS830116T , Lot Number 22KMF160 ; CDS830116T , Lot Number 22KMG955 ; CDS830116T , Lot Number 22LMD441 ; CDS830116T , Lot Number 23BME252 ; CDS830116T , Lot Number 23CME301 ; CDS830116T , Lot Number 23EMD013 ; CDS830116T , Lot Number 23GMD216 ; CDS830116T , Lot Number 23IMB391 ; CDS830116T , Lot Number 23JMA001 ; CDS830116T , Lot Number 23JMB328 ; 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CDS982762G , Lot Number 19LBU999 ; CDS982762G , Lot Number 20BBQ050 ; CDS982762G , Lot Number 20CBO879 ; CDS982762G , Lot Number 20DBG982 ; CDS982762G , Lot Number 20EBI902 ; CDS982762G , Lot Number 20FBQ714 ; CDS982762G , Lot Number 20GBV103 ; CDS982762G , Lot Number 20JBK767 ; CDS982762G , Lot Number 20KBU132 ; CDS982762G , Lot Number 20LBT638 ; CDS982762G , Lot Number 21BBL648 ; CDS982762G , Lot Number 21CBT365 ; CDS982762G , Lot Number 21FBB063 ; CDS982762I , Lot Number 21GBG901 ; CDS982762I , Lot Number 21HBC594 ; CDS982762I , Lot Number 21JBA007 ; CDS982762I , Lot Number 21JBE491 ; CDS982762I , Lot Number 21LBV622 ; CDS982762I , Lot Number 22ABM992 ; CDS982762I , Lot Number 22BBM636 ; CDS982762I , Lot Number 22OBD448 ; CDS982762I , Lot Number 22FBL398 ; CDS982762I , Lot Number 22GBR281 ; CDS982762I , Lot Number 22HBU459 ; CDS982762I , Lot Number 22IBP341 ; CDS982762I , Lot Number 22KBS611 ; CDS982762I , Lot Number 23ABE727 ; CDS982762I , Lot Number 23CBJ371 ; CDS982762I , Lot Number 23DBD995 ; CDS982762I , Lot Number 23GBO361 ; CDS982762I , Lot Number 23HBD164 ; CDS982762I , Lot Number 23IBK058 ; CDS982762I , Lot Number 23LBT991 ; CDS982762I , Lot Number 24ABT434 ; CDS982770B , Lot Number 19CBO429 ; CDS982907K , Lot Number 20IBF378 ; CDS982907L , Lot Number 21GBA017 ; CDS982907L , Lot Number 20KBK038 ; CDS982907L , Lot Number 21ABG482 ; CDS982907L , Lot Number 21BBO834 ; CDS982907L , Lot Number 21DBN022 ; CDS982908I , Lot Number 20FBV443 ; CDS982908I , Lot Number 20HBQ578 ; CDS982908I , Lot Number 20IBN502 ; CDS982908I , Lot Number 20JBR110 ; CDS982908J , Lot Number 21HBA533 ; CDS982908J , Lot Number 21IBG833 ; CDS982908J , Lot Number 21JBH428 ; CDS982908J , Lot Number 21VBD154 ; CDS982908J , Lot Number 21LBB540 ; CDS982908J , Lot Number 21LBX236 ; CDS982908J , Lot Number 22CBZ117 ; CDS982908J , Lot Number 22DBR249 ; CDS982908J , Lot Number 22FBN738 ; CDS982908J , Lot Number 22HBY954 ; CDS982908J , Lot Number 22IBC579 ; CDS982908J , Lot Number 22IBD586 ; CDS982908J , Lot Number 22IBH554 ; CDS982908J , Lot Number 22JBH312 ; CDS982908J , Lot Number 22KBB058 ; CDS982908J , Lot Number 22KBN214 ; CDS982908J , Lot Number 23ABE680 ; CDS982908J , Lot Number 23ABM506 ; CDS982908J , Lot Number 23BBJ476 ; CDS982908J , Lot Number 20KBK026 ; CDS982908J , Lot Number 20XBH011 ; CDS982908J , Lot Number 21ABG503 ; CDS982908J , Lot Number 21BBO833 ; CDS982908J , Lot Number 21CBZ463 ; CDS982908J , Lot Number 21EBF632 ; CDS982959, Lot Number 21GBF986 ; CDS982959, Lot Number 21IBK646 ; CDS982959, Lot Number 21LBU077 ; CDS982959, Lot Number 22ABT846 ; CDS982959, Lot Number 19BBH740 ; CDS982959, Lot Number 22OBL740 ; CDS982959, Lot Number 22GBM101 ; CDS982959, Lot Number 19HBC847 ; CDS982959, Lot Number 19HBJ920 ; CDS982959, Lot Number 22LBM720 ; CDS982959, Lot Number 19KBA978 ; CDS982959, Lot Number 23CBO952 ; CDS982959, Lot Number 20BBN472 ; CDS982959, Lot Number 23FBP267 ; CDS982959, Lot Number 20DBT298 ; CDS982959, Lot Number 20EBS083 ; CDS982959, Lot Number 23JBK275 ; CDS982959, Lot Number 20HBM478 ; CDS982959, Lot Number 21DBG114 ; CDS982959, Lot Number 21EBO597 ; CDS983090C , Lot Number 21GBH390 ; CDS983090C , Lot Number 21IBJ046 ; CDS983090C , Lot Number 21KBN752 ; CDS983090C , Lot Number 22ABV322 ; CDS983090C , Lot Number 22CBK077 ; CDS983090C , Lot Number 22EBG688 ; CDS983090C , Lot Number 19EBN515 ; CDS983090C , Lot Number 22FBQ247 ; CDS983090C , Lot Number 19FBW917 ; CDS983090C , Lot Number 22HBR448 ; CDS983090C , Lot Number 22IBT414 ; CDS983090C , Lot Number 22IBU544 ; CDS983090C , Lot Number 19TBD989 ; CDS983090C , Lot Number 19IBZ067 ; CDS983090C , Lot Number 23ABE729 ; CDS983090C , Lot Number 23CBQ221 ; CDS983090C , Lot Number 23FBA348 ; CDS983090C , Lot Number 20CBF618 ; CDS983090C , Lot Number 23HBG228 ; CDS983090C , Lot Number 20EBD480 ; CDS983090C , Lot Number 20FBJ393 ; CDS983090C , Lot Number 20GBU849 ; CDS983090C , Lot Number 20HBK185 ; CDS983090C , Lot Number 24ABB066 ; CDS983090C , Lot Number 20JBD425 ; CDS983090C , Lot Number 24ABS328 ; CDS983090C , Lot Number 20JBP937 ; CDS983090C , Lot Number 20WBC024 ; CDS983090C , Lot Number 20LBP515 ; CDS983107G , Lot Number 22DBJ752 ; CDS983107G , Lot Number 19HBK986 ; CDS983107G , Lot Number 23DBT115 ; CDS983107G , Lot Number 20DBF119 ; CDS983107G , Lot Number 20DBQ082 ; CDS983107G , Lot Number 20DBT422 ; CDS983107G , Lot Number 20VBB217 ; CDS983107G , Lot Number 20LBT251 ; CDS983107G , Lot Number 20LBX549 ; CDS983107G , Lot Number 21DBS568 ; CDS983107G , Lot Number 21FBH208 ; CDS983116C , Lot Number 19CBN492 ; CDS983116C , Lot Number 19DBY599 ; CDS983116C , Lot Number 19FBI734 ; CDS983116D , Lot Number 19HBR288 ; CDS983116D , Lot Number 19IBD309 ; CDS983116D , Lot Number 19VBC040 ; CDS983116D , Lot Number 19KBZ004 ; CDS983116D , Lot Number 20ABI383 ; CDS983116D , Lot Number 20DBJ070 ; CDS983116D , Lot Number 20DBT261 ; CDS983116D , Lot Number 20EBO938 ; CDS983116D , Lot Number 20GBV788 ; CDS983116D , Lot Number 20HBV904 ; CDS983116D , Lot Number 20IBH994 ; CDS983116D , Lot Number 20JBP623 ; CDS983116F , Lot Number 21BBE442 ; CDS983116F , Lot Number 21CBD966 ; CDS983116F , Lot Number 21DBY210 ; CDS983116G , Lot Number 21FBU367 ; CDS983116G , Lot Number 21GBC749 ; CDS983116G , Lot Number 21GBT671 ; CDS983116G , Lot Number 21IBR139 ; CDS983116G , Lot Number 21JBX808 ; CDS983116G , Lot Number 22NBC735 ; CDS983116I , Lot Number 22FBB086 ; CDS983116I , Lot Number 22FBG084 ; CDS983116I , Lot Number 22GBY312 ; CDS983116I , Lot Number 22HBT608 ; CDS983116I , Lot Number 22IBC541 ; CDS983116I , Lot Number 22JBD234 ; CDS983116I , Lot Number 22KBR575 ; CDS983116I , Lot Number 22LBC612 ; CDS983116I , Lot Number 23BBN532 ; CDS983116I , Lot Number 23BBN817 ; CDS983116I , Lot Number 23EBE315 ; CDS983116I , Lot Number 23GBU340 ; CDS983116I , Lot Number 23HBC598 ; CDS983116I , Lot Number 23HBL138 ; CDS983116I , Lot Number 23HBW939 ; CDS983116I , Lot Number 23IBS641 ; CDS983116I , Lot Number 23JBO011 ; CDS983116I , Lot Number 23KBO183 ; CDS983116I , Lot Number 23LBP362 ; CDS983116I , Lot Number 24ABD307 ; CDS983116I , Lot Number 24BBP100 ; CDS983119B , Lot Number 19ABU256 ; CDS983119B , Lot Number 19CBO665 ; CDS983119B , Lot Number 19FBX882 ; CDS983119B , Lot Number 19HBF324 ; CDS983119B , Lot Number 19KBT628 ; CDS983119B , Lot Number 19LBQ637 ; CDS983119B , Lot Number 20ABU024 ; CDS983119B , Lot Number 20DBN274 ; CDS983119B , Lot Number 20GBG081 ; CDS983119B , Lot Number 20KBU803 ; CDS983119B , Lot Number 21BBE946 ; CDS983268J , Lot Number 21HBT653 ; CDS983268J , Lot Number 21JBF929 ; CDS983268J , Lot Number 22BBG629 ; CDS983268L , Lot Number 22KBF768 ; CDS983268L , Lot Number 23ABM541 ; CDS983268L , Lot Number 23CBP177 ; CDS983268L , Lot Number 23EBA998 ; CDS983268L , Lot Number 23FBC773 ; CDS983268L , Lot Number 23GBW310 ; CDS983268L , Lot Number 23IBN483 ; CDS983268L , Lot Number 23JBT800 ; CDS983528J , Lot Number 21GBT595 ; CDS983528J , Lot Number 21IBR927 ; CDS983528J , Lot Number 22ABK965 ; CDS983528J , Lot Number 22BBM984 ; CDS983528J , Lot Number 22BBY278 ; CDS983528J , Lot Number 22DBC356 ; CDS983528J , Lot Number 22EBJ563 ; CDS983528J , Lot Number 22FBG648 ; CDS983528J , Lot Number 20BBQ391 ; CDS983528J , Lot Number 20DBH155 ; CDS983528J , Lot Number 20GBQ346 ; CDS983528J , Lot Number 20LBQ467 ; CDS983528J , Lot Number 21ABW662 ; CDS983528J , Lot Number 21DBA535 ; CDS983528J , Lot Number 21DBV571 ; CDS983641F , Lot Number 20GBL479 ; CDS983641G , Lot Number 20IBG248 ; CDS983641G , Lot Number 20IBM685 ; CDS983697F , Lot Number 19BDB259 ; CDS983697F , Lot Number 19EDC141 ; CDS983697F , Lot Number 19GDB381 ; CDS983697F , Lot Number 19IDA799 ; CDS983697F , Lot Number 19LDA833 ; CDS983697F , Lot Number 20BDB731 ; CDS983697F , Lot Number 20CDA002 ; CDS983697F , Lot Number 20CDA452 ; CDS983919C , Lot Number 19ABY429 ; CDS983919C , Lot Number 19DBH786 ; CDS983919C , Lot Number 19GBH588 ; CDS983919C , Lot Number 19IBY541 ; CDS983919D , Lot Number 19LBV491 ; CDS983919D , Lot Number 20CBC173 ; CDS983919D , Lot Number 20FBC041 ; CDS983919D , Lot Number 20HBM989 ; CDS983919D , Lot Number 20IBO205 ; CDS983919D , Lot Number 20LBC938 ; CDS983919F , Lot Number 21IBJ216 ; CDS983919F , Lot Number 21JBB507 ; CDS983919F , Lot Number 22BBF388 ; CDS983919F , Lot Number 22OBC138 ; CDS983919F , Lot Number 22DBN605 ; CDS983919F , Lot Number 22FBL720 ; CDS983919F , Lot Number 22GBE742 ; CDS983919F , Lot Number 22HBW180 ; CDS983919F , Lot Number 22JBC939 ; CDS983919F , Lot Number 22KBD696 ; CDS983919F , Lot Number 22KBT274 ; CDS983919F , Lot Number 22LBJ504 ; CDS983919F , Lot Number 23ABR028 ; CDS983919F , Lot Number 23CBN015 ; CDS983919F , Lot Number 23EBJ331 ; CDS983919F , Lot Number 23GBH722 ; CDS983919F , Lot Number 23GBU990 ; CDS983919F , Lot Number 23IBP584 ; CDS983919F , Lot Number 23JBB081 ; CDS983919F , Lot Number 23LBB140 ; CDS983919F , Lot Number 23LBD714 ; CDS983919F , Lot Number 21BBI374 ; CDS983919F , Lot Number 21EBK922 ; CDS983919G , Lot Number 24ABP274 ; CDS984173G , Lot Number 22BBB883 ; CDS984173G , Lot Number 22OBM455 ; CDS984173G , Lot Number 22FBD564 ; CDS984173G , Lot Number 22FBI504 ; CDS984173G , Lot Number 22HBI938 ; CDS984173G , Lot Number 22JBR312 ; CDS984173G , Lot Number 22KBF548 ; CDS984173G , Lot Number 23ABE846 ; CDS984173G , Lot Number 23BBN932 ; CDS984173G , Lot Number 23EBT372 ; CDS984173I , Lot Number 23GBL953 ; CDS984173I , Lot Number 23IBC443 ; CDS984173I , Lot Number 23JBL114 ; CDS984173I , Lot Number 23KBC018 ; CDS984173I , Lot Number 23LBV726 ; CDS984173I , Lot Number 24ABH477 ; CDS984201P , Lot Number 19ABM987 ; CDS984201P , Lot Number 19BBS363 ; CDS984201P , Lot Number 19GBW300 ; CDS984201P , Lot Number 19HBL316 ; CDS984201P , Lot Number 19HBN663 ; CDS984201Q , Lot Number 19KBO466 ; CDS984201Q , Lot Number 19LBK667 ; CDS984201Q , Lot Number 20EBE534 ; CDS984201Q , Lot Number 20GBG373 ; CDS984201R , Lot Number 20GBW206 ; CDS984201U , Lot Number 22JBP421 ; CDS984201U , Lot Number 22KBA301 ; CDS984201U , Lot Number 22KBE485 ; CDS984201U , Lot Number 22KBS048 ; CDS984201U , Lot Number 23ABG935 ; CDS984201U , Lot Number 23ABT861 ; CDS984201U , Lot Number 23CBK362 ; CDS984201U , Lot Number 23GBH493 ; CDS984235F , Lot Number 22ABV568 ; CDS984235F , Lot Number 22CBV466 ; CDS984352C , Lot Number 19CBK505 ; CDS984352C , Lot Number 19FBT822 ; CDS984352C , Lot Number 19GBS253 ; CDS984352D , Lot Number 19UBA519 ; CDS984352D , Lot Number 20ABA002 ; CDS984352D , Lot Number 20CBO944 ; CDS984352D , Lot Number 20DBK803 ; CDS984352D , Lot Number 20EBD796 ; CDS984352D , Lot Number 20GBA431 ; CDS984352D , Lot Number 20JBP449 ; CDS984352D , Lot Number 20XBH025 ; CDS984352D , Lot Number 21ABP168 ; CDS984352D , Lot Number 21CBO734 ; CDS984352F , Lot Number 21GBA695 ; CDS984352F , Lot Number 21GBD919 ; CDS984352F , Lot Number 21IBK076 ; CDS984352F , Lot Number 21VBC570 ; CDS984352F , Lot Number 22CBY935 ; CDS984352F , Lot Number 22DBG650 ; CDS984352F , Lot Number 22FBS964 ; CDS984352F , Lot Number 22FBU839 ; CDS984352F , Lot Number 22IBD688 ; CDS984352F , Lot Number 22JBH729 ; CDS984352F , Lot Number 23ABI688 ; CDS984352F , Lot Number 23CBN754 ; CDS984352F , Lot Number 23DBA328 ; CDS984352F , Lot Number 23GBT975 ; CDS984352F , Lot Number 23HBA667 ; CDS984352F , Lot Number 23IBW399 ; CDS984352F , Lot Number 23KBM707 ; CDS984352F , Lot Number 24ABJ464 ; CDS984352F , Lot Number 24BBI226 ; CDS984388B , Lot Number 21FBR752 ; CDS984388B , Lot Number 21HBV221 ; CDS984388B , Lot Number 21LBS929 ; CDS984388B , Lot Number 22BBC449 ; CDS984388B , Lot Number 22OBJ910 ; CDS984388B , Lot Number 19DBM393 ; CDS984388B , Lot Number 22FBH583 ; CDS984388B , Lot Number 19FBH719 ; CDS984388B , Lot Number 22HBK579 ; CDS984388B , Lot Number 19HBN080 ; CDS984388B , Lot Number 22JBV990 ; CDS984388B , Lot Number 19IBP489 ; CDS984388B , Lot Number 23ABR496 ; CDS984388B , Lot Number 23BBE467 ; CDS984388B , Lot Number 19WBA872 ; CDS984388B , Lot Number 23DBN637 ; CDS984388B , Lot Number 20BBS575 ; CDS984388B , Lot Number 23FBO322 ; CDS984388B , Lot Number 23HBJ721 ; CDS984388B , Lot Number 23IBK059 ; CDS984388B , Lot Number 20FBH305 ; CDS984388B , Lot Number 23JBW624 ; CDS984388B , Lot Number 20GBU493 ; CDS984388B , Lot Number 23LBL354 ; CDS984388B , Lot Number 20IBP495 ; CDS984388B , Lot Number 24BBK049 ; CDS984388B , Lot Number 21ABQ639 ; CDS984388B , Lot Number 21DBD007 ; CDS984430D , Lot Number 19CBG702 ; CDS984430F , Lot Number 21FBL041 ; CDS9

Distribution pattern

Worldwide distribution.

device · product 65 of 81

Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRAY, ER LACERATION, Pack Number DYNDL1569A; 7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ; 8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ; 9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ; 10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ; 11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ; 12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ; 13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ; 14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ; 15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ; 16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ; 17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ; 18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ; 19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ; 20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ; 21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ; 22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ; 23) PELVISCOPY PACK , Pack Number DYNJ50688D ; 24) PELVISCOPY PACK , Pack Number DYNJ50688F ; 25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ; 26) PELVIC LAP, Pack Number DYNJ53601G ; 27) VAGINAL PACK, Pack Number DYNJ59786B ; 28) PELVIC PACK , Pack Number DYNJ63057D ; 29) PELVIC PACK , Pack Number DYNJ63057F ; 30) PERI GYN, Pack Number DYNJ64239B ; 31) OB GYN PACK , Pack Number DYNJ80831; 32) MON OB GYN PACK , Pack Number DYNJ80831A ; 33) MON OB GYN PACK , Pack Number DYNJ80831B ; 34) LAP PELVISCOPY PACK , Pack Number DYNJ82449; 35) PELVISCOPY PACK , Pack Number DYNJ82555; 36) PELVISCOPY PACK , Pack Number DYNJ82555A ; 37) PELVISCOPY, Pack Number DYNJ82676; 38) PERIPELVIC PACK , Pack Number DYNJ83912; 39) PELVISCOPY PACK , Pack Number DYNJ84379; 40) PELVISCOPY PACK , Pack Number DYNJ85311; 41) D-PELVISCOPY, Pack Number DYNJ900628I; 42) PELVISCOPY, Pack Number DYNJ901655F; 43) PELVISCOPY, Pack Number DYNJ901655G; 44) PELVISCOPY, Pack Number DYNJ908446B; 45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A; 46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B

Z-3045-2024
Recall number
Z-3045-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS984187T , Lot Number 22JBX647 ; CDS984187T , Lot Number 22KBH092 ; CDS984187T , Lot Number 22KBN639 ; CDS984187T , Lot Number 23ABJ847 ; CDS984187T , Lot Number 23DBN636 ; CDS984187T , Lot Number 23EBN741 ; CDS984187T , Lot Number 23FBO660 ; CDS984187U , Lot Number 23GBV733 ; CDS984187U , Lot Number 23HBA604 ; CDS984187U , Lot Number 23JBE143 ; CDS984187U , Lot Number 23JBE436 ; CDS984187U , Lot Number 23JBX523 ; CDS984187U , Lot Number 23LBN764 ; CDS984187U , Lot Number 24BBN238 ; CDS984187U , Lot Number 24BBU609 ; DYNDA1567D, Lot Number 2019071090; DYNDA1977A, Lot Number 2019071090; DYNDH1453, Lot Number 2019071090; DYNDL1569A, Lot Number 2019071090; DYNJ0157511K , Lot Number 23LMI154 ; DYNJ0161619I , Lot Number 23EMI816 ; DYNJ0161619I , Lot Number 23FMC245 ; DYNJ0161619I , Lot Number 23FMI370 ; DYNJ0161619I , Lot Number 23HMB229 ; DYNJ0161619I , Lot Number 23KMC793 ; DYNJ0161619I , Lot Number 23KMF807 ; DYNJ0477038K , Lot Number 23CBW969 ; DYNJ0477038K , Lot Number 23EBW988 ; DYNJ0477038K , Lot Number 23HBA845 ; DYNJ0477038K , Lot Number 23IBP147 ; DYNJ0477038K , Lot Number 23LBE881 ; DYNJ0531985R , Lot Number 22HMF853 ; DYNJ0531985R , Lot Number 22LMG691 ; DYNJ0531985R , Lot Number 23AMF501 ; DYNJ0531985R , Lot Number 23CMA603 ; DYNJ0531985R , Lot Number 23DMG508 ; DYNJ0537705L , Lot Number 23FMG696 ; DYNJ0537705L , Lot Number 23IMC689 ; DYNJ0780009W , Lot Number 22HMF696 ; DYNJ0780009W , Lot Number 22JME002 ; DYNJ0780009Y , Lot Number 23EMB610 ; DYNJ0780009Y , Lot Number 23EMI825 ; DYNJ0780009Y , Lot Number 23FMA234 ; DYNJ0780009Y , Lot Number 23HMC653 ; DYNJ0780009Y , Lot Number 23JMB180 ; DYNJ0780009Y , Lot Number 23JMI648 ; DYNJ0843760I , Lot Number 23DDA645 ; DYNJ0843760I , Lot Number 23EDA680 ; DYNJ0843760J , Lot Number 23JDA821 ; DYNJ40099B , Lot Number 22ABP008 ; DYNJ40099B , Lot Number 22BBW136 ; DYNJ40099C , Lot Number 22FMB339 ; DYNJ40099C , Lot Number 22HMA727 ; DYNJ40099C , Lot Number 22IMG228 ; DYNJ40099C , Lot Number 23BMG958 ; DYNJ40099C , Lot Number 23BMH600 ; DYNJ40099C , Lot Number 23DMD083 ; DYNJ40099C , Lot Number 23DMG556 ; DYNJ40099C , Lot Number 23FMJ765 ; DYNJ40099C , Lot Number 23IMG857 ; DYNJ40099C , Lot Number 23KMJ168 ; DYNJ40099C , Lot Number 23LME309 ; DYNJ40608D , Lot Number 23GBL162 ; DYNJ40608D , Lot Number 23HBP723 ; DYNJ40608D , Lot Number 23KBF077 ; DYNJ40608D , Lot Number 23LBF535 ; DYNJ47595N , Lot Number 23CMD083 ; DYNJ47595O , Lot Number 23FMF971 ; DYNJ47595P , Lot Number 23JMC128 ; DYNJ47703G , Lot Number 23HME411 ; DYNJ50688D , Lot Number 21HMG928 ; DYNJ50688D , Lot Number 21HMH101 ; DYNJ50688D , Lot Number 22AMG373 ; DYNJ50688F , Lot Number 22HMH924 ; DYNJ50688F , Lot Number 22KMC285 ; DYNJ50688F , Lot Number 23EMA056 ; DYNJ50688F , Lot Number 23GMF859 ; DYNJ51918D , Lot Number 22IMA468 ; DYNJ51918D , Lot Number 22KMB312 ; DYNJ51918D , Lot Number 23AMA366 ; DYNJ51918D , Lot Number 23DMG134 ; DYNJ51918D , Lot Number 23HMI850 ; DYNJ51918D , Lot Number 23IMC261 ; DYNJ53601G , Lot Number 23HME948 ; DYNJ53601G , Lot Number 23KMG377 ; DYNJ59786B , Lot Number 21KMB136 ; DYNJ59786B , Lot Number 22AME269 ; DYNJ59786B , Lot Number 22DMF348 ; DYNJ59786B , Lot Number 22EMF415 ; DYNJ59786B , Lot Number 22FMB585 ; DYNJ59786B , Lot Number 22GMG722 ; DYNJ59786B , Lot Number 22IMG806 ; DYNJ59786B , Lot Number 23AMH416 ; DYNJ59786B , Lot Number 23DMC700 ; DYNJ59786B , Lot Number 23EMF594 ; DYNJ59786B , Lot Number 23EMK224 ; DYNJ59786B , Lot Number 23FMD759 ; DYNJ59786B , Lot Number 23FMI823 ; DYNJ59786B , Lot Number 23GMG644 ; DYNJ59786B , Lot Number 23JMG306 ; DYNJ63057D , Lot Number 22HMB872 ; DYNJ63057D , Lot Number 22JMC857 ; DYNJ63057D , Lot Number 22KMD431 ; DYNJ63057D , Lot Number 23CMC877 ; DYNJ63057D , Lot Number 23EMB169 ; DYNJ63057D , Lot Number 23GMF137 ; DYNJ63057D , Lot Number 23HME622 ; DYNJ63057D , Lot Number 23HMH140 ; DYNJ63057F , Lot Number 23JMB899 ; DYNJ64239B , Lot Number 23JMB243 ; DYNJ80831, Lot Number 22BBE492 ; DYNJ80831A , Lot Number 22EBH171 ; DYNJ80831A , Lot Number 22FBD558 ; DYNJ80831A , Lot Number 22HBD454 ; DYNJ80831A , Lot Number 22IBL749 ; DYNJ80831A , Lot Number 22KBP279 ; DYNJ80831A , Lot Number 23BBB408 ; DYNJ80831A , Lot Number 23CBP926 ; DYNJ80831A , Lot Number 23DBC253 ; DYNJ80831A , Lot Number 23EBJ251 ; DYNJ80831A , Lot Number 23FBG917 ; DYNJ80831B , Lot Number 23HBD666 ; DYNJ80831B , Lot Number 23IBN212 ; DYNJ80831B , Lot Number 23LBR042 ; DYNJ82449, Lot Number 22HBJ902 ; DYNJ82449, Lot Number 22LBD452 ; DYNJ82449, Lot Number 23ABP213 ; DYNJ82449, Lot Number 23EBO156 ; DYNJ82449, Lot Number 23FBB975 ; DYNJ82449, Lot Number 23FBC650 ; DYNJ82449, Lot Number 23IBU101 ; DYNJ82449, Lot Number 23JBL107 ; DYNJ82449, Lot Number 24ABD321 ; DYNJ82555, Lot Number 22HBQ035 ; DYNJ82555, Lot Number 22KBI309 ; DYNJ82555, Lot Number 22KBP238 ; DYNJ82555, Lot Number 22LBF636 ; DYNJ82555, Lot Number 23CBT455 ; DYNJ82555, Lot Number 23DBP026 ; DYNJ82555, Lot Number 23GBA449 ; DYNJ82555, Lot Number 23HBR508 ; DYNJ82555, Lot Number 23JBC557 ; DYNJ82555A , Lot Number 23KBO623 ; DYNJ82555A , Lot Number 24ABX191 ; DYNJ82676, Lot Number 22JMA911 ; DYNJ82676, Lot Number 23FMA638 ; DYNJ82676, Lot Number 23FMF414 ; DYNJ82676, Lot Number 23GMG485 ; DYNJ82676, Lot Number 23HMC846 ; DYNJ82676, Lot Number 23KMJ343 ; DYNJ82676, Lot Number 24AMA022 ; DYNJ82676, Lot Number 24AMC425 ; DYNJ83912, Lot Number 23CME427 ; DYNJ83912, Lot Number 23GMH710 ; DYNJ83912, Lot Number 23HMF033 ; DYNJ83912, Lot Number 23KMC978 ; DYNJ84379, Lot Number 23EBH463 ; DYNJ84379, Lot Number 23HBM856 ; DYNJ84379, Lot Number 23KBQ889 ; DYNJ84379, Lot Number 23LBH373 ; DYNJ84379, Lot Number 24ABD682 ; DYNJ84379, Lot Number 24ABV676 ; DYNJ85311, Lot Number 23KBA927 ; DYNJ900628I, Lot Number 22HDB961 ; DYNJ900628I, Lot Number 22JDB340 ; DYNJ900628I, Lot Number 22LDA537 ; DYNJ900628I, Lot Number 23ADA741 ; DYNJ900628I, Lot Number 23BDB733 ; DYNJ900628I, Lot Number 23DDA544 ; DYNJ900628I, Lot Number 23GDA869 ; DYNJ900628I, Lot Number 23HDB017 ; DYNJ900628I, Lot Number 23IDB957 ; DYNJ900628I, Lot Number 23KDA160 ; DYNJ900628I, Lot Number 24ADA433 ; DYNJ900628I, Lot Number 24BDC032 ; DYNJ901655F, Lot Number 22GBD980 ; DYNJ901655F, Lot Number 22GBD982 ; DYNJ901655F, Lot Number 22GBT479 ; DYNJ901655F, Lot Number 23CBD840 ; DYNJ901655F, Lot Number 23EBJ339 ; DYNJ901655F, Lot Number 23GBN897 ; DYNJ901655F, Lot Number 23HBP972 ; DYNJ901655G, Lot Number 24ABG031 ; DYNJ901655G, Lot Number 24ABI423 ; DYNJ908446B, Lot Number 22LBH624 ; DYNJ908446B, Lot Number 23ABS849 ; DYNJ908446B, Lot Number 23EBA958 ; DYNJ908446B, Lot Number 23FBD994 ; DYNJ908446B, Lot Number 23HBS818 ; DYNJ908446B, Lot Number 23JBO876 ; DYNJ908446B, Lot Number 23LBC750 ; DYNJ908459A, Lot Number 22IBE741 ; DYNJ908459A, Lot Number 22KBP958 ; DYNJ908459A, Lot Number 22LBC310 ; DYNJ908459A, Lot Number 23BBA984 ; DYNJ908459A, Lot Number 23CBX677 ; DYNJ908459B, Lot Number 23FBA018 ; DYNJ908459B, Lot Number 23FBA871 ; DYNJ908459B, Lot Number 23GBU424 ; DYNJ908459B, Lot Number 23IBA583 ; DYNJ908459B, Lot Number 23LBD444 ; DYNJ908459B, Lot Number 23LBP311

Distribution pattern

Worldwide distribution.

device · product 66 of 81

Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ; 7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ; 8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ; 9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ; 10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ; 11) GYN LAP , Pack Number CDS860087L ; 12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ; 13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ; 14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ; 15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ; 16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ; 17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ; 18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ; 19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ; 20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH; 21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ; 22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ; 23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ; 24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ; 25) LAVH CDS, Pack Number CDS920130J ; 26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ; 27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ; 28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ; 29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ; 30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ; 31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ; 32) GYN LAPAROSCOPIC, Pack Number CDS930224I ; 33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ; 34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ; 35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ; 36) ROBOTIC , Pack Number CDS980523M ; 37) ROBOTIC GYN , Pack Number CDS980647K ; 38) GYN LAP PROCEDURE , Pack Number CDS980810O ; 39) GYN LAP PROCEDURE , Pack Number CDS980810P ; 40) GYN LAP PROCEDURE , Pack Number CDS980810Q ; 41) GYN LAPAROSCOPY , Pack Number CDS980843G ; 42) GYN LAPAROSCOPY , Pack Number CDS980843I ; 43) DAVINCI PROCEDURE , Pack Number CDS980864O ; 44) DAVINCI PROCEDURE , Pack Number CDS980864P ; 45) GYN MAJOR CDS , Pack Number CDS980998J ; 46) GYN MAJOR , Pack Number CDS980998L ; 47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ; 48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ; 49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ; 50) PELVISCOPY CDS, Pack Number CDS981546F ; 51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ; 52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ; 53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ; 54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ; 55) GYN DAVINCI CDS , Pack Number CDS981606F ; 56) ROBOTIC PACK-LF , Pack Number CDS981757Q ; 57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ; 58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ; 59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ; 60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ; 61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ; 62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ; 63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ; 64) ROBOTIC CDS , Pack Number CDS981882W ; 65) ROBOTIC CDS , Pack Number CDS981882X ; 66) LITHOTOMY CDS , Pack Number CDS981897S ; 67) LITHOTOMY CDS , Pack Number CDS981897T ; 68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ; 69) GYN LAPAROSCOPY , Pack Number CDS982032U ; 70) GYN LAPAROSCOPY , Pack Number CDS982032V ; 71) GYN LAPAROSCOPY , Pack Number CDS982032W ; 72) GYN LAPAROSCOPY , Pack Number CDS982032X ; 73) GYN LAPAROSCOPY , Pack Number CDS982032Y ; 74) ROBOTIC , Pack Number CDS982046V ; 75) ROBOTIC MAJOR , Pack Number CDS982046X ; 76) ROBOTIC MAJOR , Pack Number CDS982046Y ; 77) LIVER PROCEDURE , Pack Number CDS982106J ; 78) ROBOTIC PROCEDURE , Pack Number CDS982128P ; 79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ; 80

Z-3046-2024
Recall number
Z-3046-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS760049AB, Lot Number 19ABQ398 ; CDS760049AB, Lot Number 19CBC288 ; CDS760049AB, Lot Number 19DBJ667 ; CDS760049AB, Lot Number 19FBS065 ; CDS760049AB, Lot Number 19SBD646 ; CDS760053D , Lot Number 19HBC984 ; CDS760053D , Lot Number 19IBL466 ; CDS760053D , Lot Number 19IBM566 ; CDS760053D , Lot Number 19VBH599 ; CDS760053G , Lot Number 20FBV500 ; CDS760053G , Lot Number 20GBD263 ; CDS760053G , Lot Number 20IBG285 ; CDS760053G , Lot Number 20JBL101 ; CDS760053G , Lot Number 20JBV510 ; CDS760053G , Lot Number 20LBT279 ; CDS760053G , Lot Number 21ABS479 ; CDS760053I , Lot Number 21IBF786 ; CDS760053I , Lot Number 21IBM006 ; CDS760053J , Lot Number 21KBM517 ; CDS760059F , Lot Number 19CBS256 ; CDS760059F , Lot Number 19DBM571 ; CDS760059F , Lot Number 19EBN367 ; CDS760059F , Lot Number 19FBT995 ; CDS760059F , Lot Number 19HBH102 ; CDS760059F , Lot Number 19LBQ513 ; CDS760059F , Lot Number 20CBN847 ; CDS760059F , Lot Number 20DBJ096 ; CDS760059G , Lot Number 21GBS677 ; CDS760059G , Lot Number 20GBB111 ; CDS760059G , Lot Number 20HBX520 ; CDS760059G , Lot Number 20WBE693 ; CDS760059G , Lot Number 21BBE952 ; CDS760059G , Lot Number 21EBC923 ; CDS760059I , Lot Number 21KBB608 ; CDS760059I , Lot Number 21LBB521 ; CDS760059I , Lot Number 22BBB650 ; CDS760059I , Lot Number 22CBW321 ; CDS760059I , Lot Number 22FBN206 ; CDS760059I , Lot Number 22FBO228 ; CDS760059I , Lot Number 22GBJ110 ; CDS760059I , Lot Number 22KBT168 ; CDS760059I , Lot Number 23ABK519 ; CDS760059I , Lot Number 23ABM526 ; CDS760059I , Lot Number 23CBR975 ; CDS760059I , Lot Number 23EBJ924 ; CDS760059I , Lot Number 23GBM698 ; CDS760059I , Lot Number 23IBP654 ; CDS760059J , Lot Number 23KBR541 ; CDS760059J , Lot Number 24BBO441 ; CDS860063R , Lot Number 19BBN586 ; CDS860063R , Lot Number 19BBN863 ; CDS860063R , Lot Number 19DBM867 ; CDS860063R , Lot Number 19EBN792 ; CDS860063R , Lot Number 19EBZ742 ; CDS860063R , Lot Number 19FBS583 ; CDS860087L , Lot Number 20JBM266 ; CDS860087L , Lot Number 20JBP752 ; CDS860087L , Lot Number 20KBM008 ; CDS860087L , Lot Number 20LBH803 ; CDS860087L , Lot Number 21BBA914 ; CDS860087L , Lot Number 21CBM984 ; CDS860119Q , Lot Number 19BBJ567 ; CDS860119Q , Lot Number 19BBQ131 ; CDS860119Q , Lot Number 19CBJ502 ; CDS860119Q , Lot Number 19DBD471 ; CDS860119Q , Lot Number 19EBC019 ; CDS860119R , Lot Number 19GBP590 ; CDS860119S , Lot Number 19JBR629 ; CDS860119S , Lot Number 19LBQ678 ; CDS860119S , Lot Number 20CBW864 ; CDS860119S , Lot Number 20FBF035 ; CDS860119S , Lot Number 20HBG759 ; CDS860119S , Lot Number 20IBS603 ; CDS860119S , Lot Number 20KBH282 ; CDS860119S , Lot Number 20XBI611 ; CDS860119S , Lot Number 21BBC179 ; CDS860119U , Lot Number 21FBL080 ; CDS860119U , Lot Number 21IBM843 ; CDS860119U , Lot Number 21JBX733 ; CDS860119U , Lot Number 22BBY071 ; CDS860119U , Lot Number 22OBM413 ; CDS860119U , Lot Number 22FBH802 ; CDS860119U , Lot Number 22FBY081 ; CDS860119U , Lot Number 22IBO356 ; CDS860119U , Lot Number 22IBP080 ; CDS860119U , Lot Number 22KBF557 ; CDS860119U , Lot Number 23ABA012 ; CDS860119U , Lot Number 23ABM771 ; CDS860119U , Lot Number 23CBE954 ; CDS860119U , Lot Number 23FBU676 ; CDS860119U , Lot Number 23HBV063 ; CDS860119U , Lot Number 23KBD267 ; CDS860119U , Lot Number 23KBP700 ; CDS860119U , Lot Number 24BBI127 ; CDS860119U , Lot Number 21CBO475 ; CDS860119U , Lot Number 21EBA100 ; CDS920074X , Lot Number 21HBA528 ; CDS920074X , Lot Number 21JBH454 ; CDS920074X , Lot Number 21LBR954 ; CDS920074X , Lot Number 22ABP698 ; CDS920074X , Lot Number 22BBF528 ; CDS920074X , Lot Number 22BBN752 ; CDS920074X , Lot Number 19CBD372 ; CDS920074X , Lot Number 22EBN076 ; CDS920074X , Lot Number 19EBZ739 ; CDS920074X , Lot Number 22GBJ020 ; CDS920074X , Lot Number 22GBJ558 ; CDS920074X , Lot Number 22GBQ814 ; CDS920074X , Lot Number 19GBS447 ; CDS920074X , Lot Number 22KBE741 ; CDS920074X , Lot Number 23BBD060 ; CDS920074X , Lot Number 23BBG507 ; CDS920074X , Lot Number 19KBM252 ; CDS920074X , Lot Number 23CBD877 ; CDS920074X , Lot Number 19LBQ677 ; CDS920074X , Lot Number 23EBC471 ; CDS920074X , Lot Number 20BBH342 ; CDS920074X , Lot Number 20CBC150 ; CDS920074X , Lot Number 23GBU814 ; CDS920074X , Lot Number 20EBF653 ; CDS920074X , Lot Number 23IBN679 ; CDS920074X , Lot Number 23JBT302 ; CDS920074X , Lot Number 20GBF060 ; CDS920074X , Lot Number 23LBI424 ; CDS920074X , Lot Number 20HBV919 ; CDS920074X , Lot Number 23LBS873 ; CDS920074X , Lot Number 20JBF665 ; CDS920074X , Lot Number 20JBL124 ; CDS920074X , Lot Number 20KBJ558 ; CDS920074X , Lot Number 20XBC454 ; CDS920074X , Lot Number 21BBI322 ; CDS920099Q , Lot Number 19CBA005 ; CDS920099Q , Lot Number 19CBS467 ; CDS920099Q , Lot Number 19EBH184 ; CDS920099Q , Lot Number 19EBO250 ; CDS920099Q , Lot Number 19QBD028 ; CDS920099Q , Lot Number 19GBS429 ; CDS920099Q , Lot Number 19JBT795 ; CDS920099Q , Lot Number 19KBR706 ; CDS920099Q , Lot Number 20ABQ652 ; CDS920099Q , Lot Number 20EBS162 ; CDS920099Q , Lot Number 20HBC293 ; CDS920099Q , Lot Number 20WBC015 ; CDS920099Q , Lot Number 21ABQ824 ; CDS920099Q , Lot Number 21CBD914 ; CDS920099R , Lot Number 21JBZ840 ; CDS920099R , Lot Number 21KBX774 ; CDS920099R , Lot Number 21EBD431 ; CDS920099S , Lot Number 22EBA153 ; CDS920099S , Lot Number 22GBP098 ; CDS920099S , Lot Number 22IBE827 ; CDS920099S , Lot Number 23ABC459 ; CDS920099S , Lot Number 23ABE852 ; CDS920099S , Lot Number 23ABF835 ; CDS920099S , Lot Number 23GBT006 ; CDS920099S , Lot Number 23HBS831 ; CDS920099S , Lot Number 23KBC357 ; CDS920099S , Lot Number 23LBV707 ; CDS920099SH, Lot Number 22EBA153 ; CDS920099SH, Lot Number 22GBP098 ; CDS920099SH, Lot Number 22IBE827 ; CDS920099SH, Lot Number 23ABC459 ; CDS920099SH, Lot Number 23ABE852 ; CDS920099SH, Lot Number 23ABF835 ; CDS920099SH, Lot Number 23GBT006 ; CDS920099SH, Lot Number 23HBS831 ; CDS920099SH, Lot Number 23KBC357 ; CDS920099SH, Lot Number 23LBV707 ; CDS920105D , Lot Number 19BBR799 ; CDS920105D , Lot Number 19CBT362 ; CDS920105F , Lot Number 21GBS242 ; CDS920105F , Lot Number 21JBJ712 ; CDS920105F , Lot Number 21KBB689 ; CDS920105F , Lot Number 22ABI243 ; CDS920105F , Lot Number 19FBW776 ; CDS920105F , Lot Number 22GBX678 ; CDS920105F , Lot Number 19HBF314 ; CDS920105F , Lot Number 22JBH938 ; CDS920105F , Lot Number 19IBR339 ; CDS920105F , Lot Number 19JBC612 ; CDS920105F , Lot Number 20ABU784 ; CDS920105F , Lot Number 20JBH426 ; CDS920105F , Lot Number 21BBE893 ; CDS920105F , Lot Number 21BBG015 ; CDS920105F , Lot Number 21CBI396 ; CDS920105F , Lot Number 21CBI815 ; CDS920105I , Lot Number 23LBO229 ; CDS920124J , Lot Number 21EME085 ; CDS920124J , Lot Number 21FMC610 ; CDS920124J , Lot Number 21GMF550 ; CDS920124J , Lot Number 22CMB819 ; CDS920124J , Lot Number 22DME300 ; CDS920124J , Lot Number 22EMF278 ; CDS920124J , Lot Number 22HME576 ; CDS920124J , Lot Number 22HMH620 ; CDS920124J , Lot Number 22IMD617 ; CDS920124J , Lot Number 22KMG737 ; CDS920124J , Lot Number 22LMH598 ; CDS920124J , Lot Number 23GMH968 ; CDS920124J , Lot Number 23HMI080 ; CDS920124J , Lot Number 23IMF066 ; CDS920124J , Lot Number 24AME652 ; CDS920124J , Lot Number 19HKB135 ; CDS920124J , Lot Number 19JKA538 ; CDS920124J , Lot Number 19LKB632 ; CDS920124J , Lot Number 20GKA088 ; CDS920124J , Lot Number 20GKB281 ; CDS920124J , Lot Number 20HKA339 ; CDS920124J , Lot Number 20IKA353 ; CDS920124J , Lot Number 20KKB205 ; CDS920124J , Lot Number 20LKB219 ; CDS920124J , Lot Number 21BKA412 ; CDS920124J , Lot Number 21CKA221 ; CDS920130J , Lot Number 21HMC146 ; CDS920130J , Lot Number 21HMD897 ; CDS920130J , Lot Number 21JMA960 ; CDS920130J , Lot Number 22EMB969 ; CDS920130J , Lot Number 22EMH738 ; CDS920130J , Lot Number 22JMF356 ; CDS920130J , Lot Number 22LMC714 ; CDS920130J , Lot Number 19DKA020 ; CDS920130J , Lot Number 19DKA968 ; CDS920130J , Lot Number 19EKB184 ; CDS920130J , Lot Number 19GKA794 ; CDS920130J , Lot Number 19HKB922 ; CDS920130J , Lot Number 19JKB113 ; CDS920130J , Lot Number 19LKA109 ; CDS920130J , Lot Number 20AKB399 ; CDS920130J , Lot Number 20BKA490 ; CDS920130J , Lot Number 20CKA894 ; CDS930198S , Lot Number 19ABO166 ; CDS930198S , Lot Number 19CBB270 ; CDS930198T , Lot Number 19GBM575 ; CDS930198T , Lot Number 19GBS038 ; CDS930198T , Lot Number 19HBG585 ; CDS930198U , Lot Number 21GBN145 ; CDS930198U , Lot Number 21HBV220 ; CDS930198U , Lot Number 21IBP939 ; CDS930198U , Lot Number 19SBE763 ; CDS930198U , Lot Number 19HBG803 ; CDS930198U , Lot Number 19UBA584 ; CDS930198U , Lot Number 19VBG617 ; CDS930198U , Lot Number 19WBA858 ; CDS930198U , Lot Number 20ABH023 ; CDS930198U , Lot Number 20BBK653 ; CDS930198U , Lot Number 20CBP667 ; CDS930198U , Lot Number 20EBS253 ; CDS930198U , Lot Number 20GBR022 ; CDS930198U , Lot Number 20IBG999 ; CDS930198U , Lot Number 21ABH875 ; CDS930198U , Lot Number 21DBP237 ; CDS930198V , Lot Number 22NBF707 ; CDS930198V , Lot Number 22CBE776 ; CDS930198V , Lot Number 22DMB434 ; CDS930198V , Lot Number 22DMH535 ; CDS930198W , Lot Number 22FME537 ; CDS930198X , Lot Number 22FMG585 ; CDS930198X , Lot Number 22GMA941 ; CDS930198X , Lot Number 22HMB061 ; CDS930198X , Lot Number 22JMG032 ; CDS930198X , Lot Number 22KMF952 ; CDS930198X , Lot Number 22KMG582 ; CDS930198X , Lot Number 22LMH721 ; CDS930224I , Lot Number 21GBF946 ; CDS930224I , Lot Number 21IBJ244 ; CDS930224I , Lot Number 21VBB238 ; CDS930224I , Lot Number 21LBE719 ; CDS930224I , Lot Number 22ABV308 ; CDS930224I , Lot Number 19BBD507 ; CDS930224I , Lot Number 22CBY820 ; CDS930224I , Lot Number 19CBM450 ; CDS930224I , Lot Number 22EBK617 ; CDS930224I , Lot Number 19EBP765 ; CDS930224I , Lot Number 22FBU431 ; CDS930224I , Lot Number 19GBB612 ; CDS930224I , Lot Number 22HBH502 ; CDS930224I , Lot Number 22IBF740 ; CDS930224I , Lot Number 19HBW096 ; CDS930224I , Lot Number 19IBF804 ; CDS930224I , Lot Number 22KBC726 ; CDS930224I , Lot Number 22LBG980 ; CDS930224I , Lot Number 23ABC564 ; CDS930224I , Lot Number 19KBE823 ; CDS930224I , Lot Number 23DBF763 ; CDS930224I , Lot Number 23EBL736 ; CDS930224I , Lot Number 20BBA099 ; CDS930224I , Lot Number 23FBK859 ; CDS930224I , Lot Number 23HBE231 ; CDS930224I , Lot Number 20GBC048 ; CDS930224I , Lot Number 20HBI367 ; 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CDS982409B , Lot Number 22DBS500 ; CDS982409B , Lot Number 19EBK186 ; CDS982409B , Lot Number 22GBF547 ; CDS982409B , Lot Number 19GBO671 ; CDS982409B , Lot Number 22IBF601 ; CDS982409B , Lot Number 22JBB909 ; CDS982409B , Lot Number 19IBD012 ; CDS982409B , Lot Number 22KBN942 ; CDS982409B , Lot Number 19JBZ634 ; CDS982409B , Lot Number 23BBU074 ; CDS982409B , Lot Number 19LBG155 ; CDS982409B , Lot Number 23CBU290 ; CDS982409B , Lot Number 20ABR783 ; CDS982409B , Lot Number 23EBT905 ; CDS982409B , Lot Number 20CBW979 ; CDS982409B , Lot Number 23GBV747 ; CDS982409B , Lot Number 23HBU564 ; CDS982409B , Lot Number 20EBI819 ; CDS982409B , Lot Number 20FBW336 ; CDS982409B , Lot Number 23JBS906 ; CDS982409B , Lot Number 23LBJ470 ; CDS982409B , Lot Number 20IBD964 ; CDS982409B , Lot Number 24BBI062 ; CDS982409B , Lot Number 20LBF051 ; CDS982409B , Lot Number 21ABS082 ; CDS982409B , Lot Number 21DBG121 ; CDS982488K , Lot Number 19BDA592 ; CDS982488K , Lot Number 19CDD202 ; CDS982488K , Lot Number 19EDB205 ; CDS982488K , Lot Number 19GDA248 ; CDS982488K , Lot Number 19IDB186 ; CDS982488K , Lot Number 19IDB558 ; CDS982488K , Lot Number 19KDC371 ; CDS982488K , Lot Number 20BDA894 ; CDS982591K , Lot Number 21LMA320 ; CDS982606I , Lot Number 21KMH201 ; CDS982607K , Lot Number 21KMG877 ; CDS982662M , Lot Number 19BBN663 ; CDS982662M , Lot Number 19DBJ801 ; CDS982662N , Lot Number 19QBA183 ; CDS982662N , Lot Number 19GBO321 ; CDS982662N , Lot Number 19HBA532 ; CDS982662O , Lot Number 19JBE326 ; CDS982662O , Lot Number 19KBF420 ; CDS982662O , Lot Number 19KBT842 ; CDS982662O , Lot Number 19LBV462 ; CDS982662O , Lot Number 20CBV696 ; CDS982662O , Lot Number 20CBY267 ; CDS982662O , Lot Number 20DBU554 ; CDS982662O , Lot Number 20FBU283 ; CDS982662O , Lot Number 20GBU942 ; CDS982662O , Lot Number 20HBU664 ; CDS982662O , Lot Number 20IBS595 ; CDS982662O , Lot Number 20JBO712 ; CDS982662O , Lot Number 20KBR862 ; CDS982662O , Lot Number 21ABP688 ; CDS982662O , Lot Number 21ABW355 ; CDS982679L , Lot Number 21FME047 ; CDS982679L , Lot Number 21IMA034 ; CDS982679L , Lot Number 21LME776 ; CDS982679L , Lot Number 19AKA700 ; CDS982679L , Lot Number 19CKA534 ; CDS982679L , Lot Number 19EKC220 ; CDS982679L , Lot Number 19HKA043 ; CDS982679L , Lot Number 19IKA718 ; CDS982679L , Lot Number 19IKA890 ; CDS982679L , Lot Number 19JKB869 ; CDS982679L , Lot Number 20AKB226 ; CDS982679L , Lot Number 20CKA734 ; CDS982679L , Lot Number 20IKB337 ; CDS982679L , Lot Number 20LKA128 ; CDS982679L , Lot Number 21DKA075 ; CDS982725L , Lot Number 19IBS888 ; CDS982725L , Lot Number 19LBN315 ; CDS982725L , Lot Number 20BBN575 ; CDS982725L , Lot Number 20OBA201 ; CDS982725L , Lot Number 20DBP910 ; CDS982725L , Lot Number 20FBC059 ; CDS982725L , Lot Number 20GBB099 ; CDS982725L , Lot Number 20IBQ467 ; CDS982725O , Lot Number 22JBR891 ; CDS982725O , Lot Number 22KBC304 ; CDS982725O , Lot Number 22KBT277 ; CDS982725O , Lot Number 23CBJ502 ; CDS982725O , Lot Number 23CBX465 ; CDS982725O , Lot Number 23DBM973 ; CDS982725O , Lot Number 23GBL984 ; CDS982725O , Lot Number 23KBF949 ; CDS982725O , Lot Number 23KBW247 ; CDS982725O , Lot Number 24BBL544 ; CDS982727J , Lot Number 21FBL935 ; CDS982727J , Lot Number 21HBT610 ; CDS982727J , Lot Number 21IBM955 ; CDS982727J , Lot Number 21KBG314 ; CDS982727J , Lot Number 22BBH036 ; CDS982727J , Lot Number 22DBN463 ; CDS982727J , Lot Number 21DBO223 ; CDS982727J , Lot Number 21DBU891 ; CDS982727K , Lot Number 22FBG590 ; CDS982727K , Lot Number 22GBV038 ; CDS982727K , Lot Number 22HBT918 ; CDS982727L , Lot Number 22KBR933 ; CDS982727L , Lot Number 23ABI378 ; CDS982727L , Lot Number 23BBM211 ; CDS982727L , Lot Number 23CBO776 ; CDS982727L , Lot Number 23DBF746 ; CDS982727L , Lot Number 23DBQ561 ; CDS982727L , Lot Number 23FBB707 ; CDS982727L , Lot Number 23FBP579 ; CDS982727L , Lot Number 23IBU402 ; CDS982727L , Lot Number 23JBU722 ; CDS982727L , Lot Number 23KBL302 ; CDS982727L , Lot Number 24BBC548 ; CDS982731O , Lot Number 22BMF647 ; CDS982731O , Lot Number 22DMB456 ; CDS982731O , Lot Number 22FMD337 ; CDS982731O , Lot Number 22HMA004 ; CDS982731O , Lot Number 23AMB748 ; CDS982731O , Lot Number 23BMI326 ; CDS982731O , Lot Number 23CMG432 ; CDS982731O , Lot Number 23GMA378 ; CDS982731O , Lot Number 23HME853 ; CDS982731O , Lot Number 23JMI275 ; CDS982731O , Lot Number 23LMB991 ; CDS982731O , Lot Number 24AME925 ; CDS982732K , Lot Number 19BKD747 ; CDS982732K , Lot Number 19EKA119 ; CDS982732L , Lot Number 21KMB553 ; CDS982732L , Lot Number 21KMH399 ; CDS982732L , Lot Number 21LMG806 ; CDS982748D , Lot Number 19ABQ272 ; CDS982748D , Lot Number 19BBN162 ; CDS982748D , Lot Number 19DBN531 ; CDS982748D , Lot Number 19EBI584 ; CDS982748D , Lot Number 19FBD106 ; CDS982748F , Lot Number 19GBD577 ; CDS982748G , Lot Number 19HBP057 ; CDS982748G , Lot Number 19IBD260 ; CDS982748G , Lot Number 19LBW332 ; CDS982780Q , Lot Number 19PBC856 ; CDS982780Q , Lot Number 19GBW299 ; CDS982780R , Lot Number 19HBW385 ; CDS982780R , Lot Number 19IBC640 ; CDS982780R , Lot Number 19KBA649 ; CDS982780R , Lot Number 19KBB917 ; CDS982780R , Lot Number 20ABH028 ; CDS982780R , Lot Number 20OBA202 ; CDS982780R , Lot Number 20DBO903 ; CDS982780R , Lot Number 20EBC262 ; CDS982780R , Lot Number 20EBI785 ; CDS982780R , Lot Number 20EBV319 ; CDS982780R , Lot Num

Distribution pattern

Worldwide distribution.

device · product 67 of 81

Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Number DYNDL1813; 6) CIRCUMCISION PACK , Pack Number DYNJ16826M ; 7) CIRCUMCISION PACK , Pack Number DYNJ16826N ; 8) CIRCUMCISION PACK , Pack Number DYNJ16826O ; 9) CIRCUMCISION PACK , Pack Number DYNJ38941D ; 10) CIRCUMCISION PACK , Pack Number DYNJ38941F ; 11) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471D ; 12) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471F ; 13) CRMC UNIVERSAL PACK-LF, Pack Number DYNJ61119C ; 14) D-CIRCUMCISION PACK , Pack Number DYNJ64432; 15) CIRCUMCISION PACK , Pack Number DYNJ64876A ; 16) CIRCUMCISION PACK , Pack Number DYNJ64876B ; 17) PACK,CIRCUMCISION ASC , Pack Number DYNJ906909A

Z-3047-2024
Recall number
Z-3047-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS980371J , Lot Number 19BBJ528 ; CDS980371J , Lot Number 19BBS356 ; CDS980371J , Lot Number 19DBR965 ; CDS980371J , Lot Number 19EBX731 ; CDS980371J , Lot Number 19GBJ926 ; CDS980371J , Lot Number 19HBY831 ; CDS980371J , Lot Number 19IBL323 ; CDS980371K , Lot Number 21GBD850 ; CDS980371K , Lot Number 21HBI925 ; CDS980371K , Lot Number 21JBJ715 ; CDS980371K , Lot Number 19LBF128 ; CDS980371K , Lot Number 20BBU821 ; CDS980371K , Lot Number 20FBB764 ; CDS980371K , Lot Number 20GBR055 ; CDS980371K , Lot Number 20JBT054 ; CDS980371K , Lot Number 20LBC968 ; CDS980371K , Lot Number 21BBE923 ; CDS980371K , Lot Number 21BBG105 ; CDS980371K , Lot Number 21DBL086 ; CIT6260A , Lot Number 22LBQ691 ; CIT6260A , Lot Number 23ABQ560 ; CIT6260A , Lot Number 23EBS513 ; CIT6260A , Lot Number 23HBT731 ; CIT6260A , Lot Number 23LBT432 ; CIT7740, Lot Number 23DBE831 ; CIT7740, Lot Number 23IBR327 ; DYNDL1813, Lot Number 20FBD708 ; DYNJ16826M , Lot Number 20KME235 ; DYNJ16826M , Lot Number 20LMD829 ; DYNJ16826M , Lot Number 20LME603 ; DYNJ16826M , Lot Number 21BMD922 ; DYNJ16826M , Lot Number 21DMC310 ; DYNJ16826M , Lot Number 21GMC003 ; DYNJ16826M , Lot Number 21HMG078 ; DYNJ16826N , Lot Number 21JMF750 ; DYNJ16826N , Lot Number 21LMF895 ; DYNJ16826N , Lot Number 22CMF391 ; DYNJ16826N , Lot Number 22DMG155 ; DYNJ16826N , Lot Number 22FMB133 ; DYNJ16826N , Lot Number 22IMA881 ; DYNJ16826N , Lot Number 22KMF328 ; DYNJ16826N , Lot Number 23AMA622 ; DYNJ16826N , Lot Number 23BMG816 ; DYNJ16826N , Lot Number 23DMA339 ; DYNJ16826O , Lot Number 23FMC064 ; DYNJ16826O , Lot Number 23GMC962 ; DYNJ16826O , Lot Number 23GMG544 ; DYNJ16826O , Lot Number 23HMI663 ; DYNJ16826O , Lot Number 23JMH529 ; DYNJ16826O , Lot Number 24AMA886 ; DYNJ38941D , Lot Number 19BBN390 ; DYNJ38941D , Lot Number 19CBE691 ; DYNJ38941D , Lot Number 19EBK155 ; DYNJ38941D , Lot Number 19FBW883 ; DYNJ38941D , Lot Number 19SBF056 ; DYNJ38941D , Lot Number 19IBO888 ; DYNJ38941D , Lot Number 19KBM786 ; DYNJ38941D , Lot Number 19LBV953 ; DYNJ38941D , Lot Number 20ABG192 ; DYNJ38941D , Lot Number 20CBS685 ; DYNJ38941D , Lot Number 20EBQ929 ; DYNJ38941D , Lot Number 20GBD152 ; DYNJ38941D , Lot Number 20IMA917 ; DYNJ38941D , Lot Number 20JMA465 ; DYNJ38941D , Lot Number 21BMB204 ; DYNJ38941D , Lot Number 21CMC018 ; DYNJ38941D , Lot Number 21CMC276 ; DYNJ38941D , Lot Number 21EMB640 ; DYNJ38941D , Lot Number 21GMA293 ; DYNJ38941D , Lot Number 21HME096 ; DYNJ38941F , Lot Number 21JMF900 ; DYNJ38941F , Lot Number 21JMG634 ; DYNJ38941F , Lot Number 21LMA419 ; DYNJ38941F , Lot Number 21LMB262 ; DYNJ38941F , Lot Number 22AMC764 ; DYNJ38941F , Lot Number 22BMH048 ; DYNJ38941F , Lot Number 22DMB792 ; DYNJ38941F , Lot Number 22EMD006 ; DYNJ38941F , Lot Number 22FMG928 ; DYNJ38941F , Lot Number 22IMA224 ; DYNJ38941F , Lot Number 22KMB540 ; DYNJ38941F , Lot Number 22LMI658 ; DYNJ38941F , Lot Number 22LMI659 ; DYNJ38941F , Lot Number 23BMA793 ; DYNJ38941F , Lot Number 23BMB118 ; DYNJ48471D , Lot Number 21HBN088 ; DYNJ48471D , Lot Number 21HBN097 ; DYNJ48471D , Lot Number 21LBF729 ; DYNJ48471D , Lot Number 22BBN858 ; DYNJ48471D , Lot Number 22FBA176 ; DYNJ48471D , Lot Number 22GBM022 ; DYNJ48471D , Lot Number 22HBR350 ; DYNJ48471D , Lot Number 19HBG760 ; DYNJ48471D , Lot Number 19IBS581 ; DYNJ48471D , Lot Number 19JBH818 ; DYNJ48471D , Lot Number 23FBD447 ; DYNJ48471D , Lot Number 20KBF714 ; DYNJ48471F , Lot Number 23HBB460 ; DYNJ48471F , Lot Number 23KBH955 ; DYNJ48471F , Lot Number 23KBU382 ; DYNJ61119C , Lot Number 20IBT137 ; DYNJ61119C , Lot Number 20WBI854 ; DYNJ61119C , Lot Number 20LBH019 ; DYNJ61119C , Lot Number 21CBN114 ; DYNJ61119C , Lot Number 21FMD836 ; DYNJ61119C , Lot Number 21GME522 ; DYNJ61119C , Lot Number 21HME553 ; DYNJ61119C , Lot Number 21IMD979 ; DYNJ61119C , Lot Number 21JMA125 ; DYNJ61119C , Lot Number 21KMF555 ; DYNJ61119C , Lot Number 21LMG365 ; DYNJ64432, Lot Number 21IDA848 ; DYNJ64432, Lot Number 21KDC323 ; DYNJ64432, Lot Number 22ADA261 ; DYNJ64432, Lot Number 22CDC116 ; DYNJ64432, Lot Number 22DDC463 ; DYNJ64432, Lot Number 22GDA264 ; DYNJ64432, Lot Number 22HDB210 ; DYNJ64432, Lot Number 22JDA234 ; DYNJ64432, Lot Number 22KDA275 ; DYNJ64432, Lot Number 23BDA297 ; DYNJ64432, Lot Number 23DDC249 ; DYNJ64432, Lot Number 23FDB680 ; DYNJ64432, Lot Number 23GDB911 ; DYNJ64432, Lot Number 23IDA043 ; DYNJ64432, Lot Number 23JDC211 ; DYNJ64876A , Lot Number 21GBB289 ; DYNJ64876A , Lot Number 21HBE385 ; DYNJ64876A , Lot Number 21HBQ607 ; DYNJ64876A , Lot Number 21JBK246 ; DYNJ64876A , Lot Number 21JBU656 ; DYNJ64876A , Lot Number 21KBG007 ; DYNJ64876A , Lot Number 21LBQ521 ; DYNJ64876A , Lot Number 21LBW552 ; DYNJ64876A , Lot Number 22CBM771 ; DYNJ64876A , Lot Number 22HBK326 ; DYNJ64876A , Lot Number 22JBF576 ; DYNJ64876A , Lot Number 22KBG724 ; DYNJ64876A , Lot Number 20HBP009 ; DYNJ64876A , Lot Number 20JBD838 ; DYNJ64876A , Lot Number 20JBG527 ; DYNJ64876A , Lot Number 20JBK521 ; DYNJ64876A , Lot Number 20KBN606 ; DYNJ64876A , Lot Number 21ABW616 ; DYNJ64876A , Lot Number 21CBP857 ; DYNJ64876B , Lot Number 22LBN031 ; DYNJ64876B , Lot Number 23GBL751 ; DYNJ64876B , Lot Number 23IBP497 ; DYNJ64876B , Lot Number 23JBG687 ; DYNJ64876B , Lot Number 23KBI407 ; DYNJ64876B , Lot Number 24ABA124 ; DYNJ906909A, Lot Number 23ABE857 ; DYNJ906909A, Lot Number 23DBD597 ; DYNJ906909A, Lot Number 23DBE346 ; DYNJ906909A, Lot Number 23FBK478 ; DYNJ906909A, Lot Number 23GBI807 ; DYNJ906909A, Lot Number 23HBR596 ; DYNJ906909A, Lot Number 23IBC034 ; DYNJ906909A, Lot Number 23KBH128 ; DYNJ906909A, Lot Number 24ABT698

Distribution pattern

Worldwide distribution.

device · product 68 of 81

Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack Number CDS820081L ; 7) C-SECTION CDS , Pack Number CDS820103J ; 8) C-SECTION CDS , Pack Number CDS820103K ; 9) UVALDE C-SECTION CDS, Pack Number CDS820116F ; 10) UVALDE C-SECTION CDS, Pack Number CDS820116G ; 11) C-SECTION CDS , Pack Number CDS820136O ; 12) C-SECTION CDS , Pack Number CDS820136P ; 13) C-SECTION CDS , Pack Number CDS820136Q ; 14) C-SECTION CDS , Pack Number CDS820136R ; 15) C-SECTION CDS , Pack Number CDS820136S ; 16) C-SECTION CDS , Pack Number CDS820136T ; 17) C-SECTION CDS , Pack Number CDS820136U ; 18) C-SECTION CDS , Pack Number CDS820152F ; 19) C-SECTION CDS , Pack Number CDS820152G ; 20) C-SECTION CDS , Pack Number CDS820152I ; 21) C-SECTION CDS , Pack Number CDS980774J ; 22) C-SECTION , Pack Number CDS980774K ; 23) C-SECTION , Pack Number CDS980774L ; 24) C-SECTION , Pack Number CDS980774M ; 25) C-SECTION CDS WOR-LF, Pack Number CDS981707F ; 26) C-SECTION CDS , Pack Number CDS981777L ; 27) C-SECTION CDS , Pack Number CDS981777M ; 28) C-SECTION CDS , Pack Number CDS981777N ; 29) C-SECTION CDS-LF, Pack Number CDS982258F ; 30) C-SECTION CDS-LF, Pack Number CDS982258G ; 31) C-SECTION CDS-LF, Pack Number CDS982258I ; 32) C-SECTION CDS , Pack Number CDS982267F ; 33) C-SECTION CDS , Pack Number CDS982267G ; 34) C-SECTION CDS , Pack Number CDS982267I ; 35) C-SECTION CDS , Pack Number CDS982267J ; 36) C-SECTION CDS , Pack Number CDS982328J ; 37) C-SECTION CDS , Pack Number CDS982328K ; 38) C-SECTION CDS , Pack Number CDS982328L ; 39) C-SECTION CDS , Pack Number CDS982328M ; 40) C-SECTION CDS , Pack Number CDS982328O ; 41) C-SECTION CDS , Pack Number CDS982328P ; 42) C-SECTION CDS , Pack Number CDS982367G ; 43) C-SECTION COMBINED CDS, Pack Number CDS982398G ; 44) C-SECTION COMBINED CDS, Pack Number CDS982398I ; 45) C-SECTION CDS , Pack Number CDS982416O ; 46) C SECTION CDS CHS , Pack Number CDS982739F ; 47) C SECTION CDS CHS , Pack Number CDS982739J ; 48) C-SECTION CDS , Pack Number CDS983117C ; 49) C-SECTION CDS , Pack Number CDS983117D ; 50) C-SECTION CDS , Pack Number CDS983117F ; 51) C-SECTION CDS , Pack Number CDS983117G ; 52) C-SECTION PROCEDURE , Pack Number CDS983450I ; 53) C-SECTION PROCEDURE , Pack Number CDS983450J ; 54) C-SECTION PROCEDURE , Pack Number CDS983450K ; 55) C-SECTION PROCEDURE , Pack Number CDS983450L ; 56) C-SECTION PROCEDURE , Pack Number CDS983450M ; 57) C-SECTION CDS , Pack Number CDS983523D ; 58) C-SECTION CDS , Pack Number CDS983523F ; 59) C-SECTION CDS , Pack Number CDS983523G ; 60) C-SECTION CDS-LF, Pack Number CDS983869I ; 61) C-SECTION-LF, Pack Number CDS983869J ; 62) C-SECTION CDS , Pack Number CDS983897G ; 63) C-SECTION CDS , Pack Number CDS983897I ; 64) C-SECTION CDS , Pack Number CDS983934I ; 65) C-SECTION CDS , Pack Number CDS983998C ; 66) C-SECTION DELIVERY CDS, Pack Number CDS984018; 67) C-SECTION DELIVERY CDS, Pack Number CDS984018A ; 68) C-SECTION CDS , Pack Number CDS984554B ; 69) C SECTION CDS , Pack Number CDS984616A ; 70) C-SECTION CDS , Pack Number CDS984768D ; 71) C-SECTION CDS , Pack Number CDS984768F ; 72) C-SECTION , Pack Number CDS984902G ; 73) C-SECTION , Pack Number CDS984902I ; 74) C-SECTION , Pack Number CDS984902J ; 75) C-SECTION , Pack Number CDS984902K ; 76) C-SECTION CDS , Pack Number CDS985206B ; 77) C-SECTION CDS , Pack Number CDS985257G ; 78) C-SECTION CDS , Pack Number CDS985257I ; 79) C-SECTION CDS , Pack Number CDS985257J ; 80) C-SECTION CDS , Pack Number CDS985257L ; 81) C SECTION , Pack Number CDS985505G ; 82) C-SECTION , Pack Number CDS985560N ; 83) C-SECTION SET-UP PACK , Pack Number CDSOBL122F ; 84) C-SECTION SET-UP PACK , Pack Number CDSOBL122G ; 85) C-SECTION SET-UP PACK , Pack Number CD

Z-3048-2024
Recall number
Z-3048-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

AM160B , Lot Number 19DBG798 ; AM160B , Lot Number 19DBT073 ; AM160B , Lot Number 19GBK115 ; AM160B , Lot Number 19TBB002 ; AM160B , Lot Number 19IBN286 ; AM160B , Lot Number 19KBF062 ; AM160C , Lot Number 21FBM171 ; AM160C , Lot Number 20ABB878 ; AM160C , Lot Number 20BBW406 ; AM160C , Lot Number 20CBA975 ; AM160C , Lot Number 20DBD025 ; AM160C , Lot Number 20GBG950 ; AM160C , Lot Number 20HBV795 ; AM160C , Lot Number 21BBF298 ; AM160C , Lot Number 21BBF425 ; CDS820031I , Lot Number 19BBK847 ; CDS820031I , Lot Number 19CBE063 ; CDS820031J , Lot Number 21FBL439 ; CDS820031J , Lot Number 21GBE677 ; CDS820031J , Lot Number 21JBF745 ; CDS820031J , Lot Number 21JBN716 ; CDS820031J , Lot Number 21JBY908 ; CDS820031J , Lot Number 21KBP597 ; CDS820031J , Lot Number 21WBA979 ; CDS820031J , Lot Number 19DBM904 ; CDS820031J , Lot Number 19EBM237 ; CDS820031J , Lot Number 19FBO038 ; CDS820031J , Lot Number 19GBF747 ; CDS820031J , Lot Number 22IBI048 ; CDS820031J , Lot Number 22KBF508 ; CDS820031J , Lot Number 22KBN688 ; CDS820031J , Lot Number 19JBC701 ; CDS820031J , Lot Number 19JBU877 ; CDS820031J , Lot Number 23ABE785 ; CDS820031J , Lot Number 19JBZ086 ; CDS820031J , Lot Number 23BBR695 ; CDS820031J , Lot Number 20BBK590 ; CDS820031J , Lot Number 20BBS508 ; CDS820031J , Lot Number 20BBZ094 ; CDS820031J , Lot Number 23IBH234 ; CDS820031J , Lot Number 20FBA127 ; CDS820031J , Lot Number 23JBD093 ; CDS820031J , Lot Number 23JBW122 ; CDS820031J , Lot Number 20GBK469 ; CDS820031J , Lot Number 23LBF496 ; CDS820031J , Lot Number 20IBD516 ; CDS820031J , Lot Number 24ABA511 ; CDS820031J , Lot Number 20IBO694 ; CDS820031J , Lot Number 24BBA399 ; CDS820031J , Lot Number 24CBJ244 ; CDS820031J , Lot Number 20WBA829 ; CDS820031J , Lot Number 21ABO446 ; CDS820031J , Lot Number 21CBD958 ; CDS820081K , Lot Number 19AKA693 ; CDS820081K , Lot Number 19AKC737 ; CDS820081K , Lot Number 19CKD083 ; CDS820081K , Lot Number 19EKC898 ; CDS820081K , Lot Number 19GKB790 ; CDS820081K , Lot Number 19IKB089 ; CDS820081L , Lot Number 21GBM225 ; CDS820081L , Lot Number 21JBT012 ; CDS820081L , Lot Number 21KBK329 ; CDS820081L , Lot Number 21LBV275 ; CDS820081L , Lot Number 22BBJ584 ; CDS820081L , Lot Number 22CBP343 ; CDS820081L , Lot Number 22OBE864 ; CDS820081L , Lot Number 22IBA261 ; CDS820081L , Lot Number 22IBA535 ; CDS820081L , Lot Number 22IBF598 ; CDS820081L , Lot Number 22IBF818 ; CDS820081L , Lot Number 22LBJ357 ; CDS820081L , Lot Number 23BBO837 ; CDS820081L , Lot Number 23DBD629 ; CDS820081L , Lot Number 23FBL414 ; CDS820081L , Lot Number 23IBE629 ; CDS820081L , Lot Number 23JBM618 ; CDS820081L , Lot Number 23LBV769 ; CDS820081L , Lot Number 21EBH607 ; CDS820081L , Lot Number 19JKB104 ; CDS820081L , Lot Number 20BKA197 ; CDS820081L , Lot Number 20EKA149 ; CDS820081L , Lot Number 20EKB971 ; CDS820081L , Lot Number 20HKA772 ; CDS820081L , Lot Number 20JKA732 ; CDS820081L , Lot Number 21AKA513 ; CDS820081L , Lot Number 21BKA781 ; CDS820081L , Lot Number 21DKA368 ; CDS820103J , Lot Number 19ABL764 ; CDS820103J , Lot Number 19BBS005 ; 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CDS983869J , Lot Number 24ADA494 ; CDS983869J , Lot Number 24CDB115 ; CDS983897G , Lot Number 19CDB807 ; CDS983897G , Lot Number 19FDA817 ; CDS983897G , Lot Number 19HDD245 ; CDS983897G , Lot Number 20ADC658 ; CDS983897I , Lot Number 20ADC098 ; CDS983897I , Lot Number 20DDB486 ; CDS983897I , Lot Number 20FDA563 ; CDS983897I , Lot Number 20HDA248 ; CDS983897I , Lot Number 20IDC237 ; CDS983897I , Lot Number 20LDA786 ; CDS983897I , Lot Number 21BDB640 ; CDS983897I , Lot Number 21DDB386 ; CDS983897I , Lot Number 21EDB085 ; CDS983897I , Lot Number 21HDA267 ; CDS983897I , Lot Number 21IDB152 ; CDS983897I , Lot Number 21LDA002 ; CDS983897I , Lot Number 21LDB157 ; CDS983897I , Lot Number 22BDA034 ; CDS983897I , Lot Number 22EDA643 ; CDS983897I , Lot Number 22IDC097 ; CDS983897I , Lot Number 22KDC244 ; CDS983897I , Lot Number 22LDB132 ; CDS983897I , Lot Number 23BDB795 ; CDS983934I , Lot Number 21FBI216 ; CDS983934I , Lot Number 21GBG967 ; CDS983934I , Lot Number 21IBM812 ; CDS983934I , Lot Number 21JBX746 ; 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CDS983934I , Lot Number 23JME980 ; CDS983998C , Lot Number 21HBF196 ; CDS983998C , Lot Number 21JBF986 ; CDS983998C , Lot Number 21JBQ461 ; CDS983998C , Lot Number 22BBE878 ; CDS983998C , Lot Number 22HBC905 ; CDS983998C , Lot Number 22HBZ254 ; CDS983998C , Lot Number 23ABI006 ; CDS983998C , Lot Number 23CBJ920 ; CDS983998C , Lot Number 20ABG819 ; CDS983998C , Lot Number 23EBN740 ; CDS983998C , Lot Number 20BBC565 ; CDS983998C , Lot Number 23FBT058 ; CDS983998C , Lot Number 20CBN687 ; CDS983998C , Lot Number 23GBR762 ; CDS983998C , Lot Number 23GBR790 ; CDS983998C , Lot Number 23JBN978 ; CDS983998C , Lot Number 23KBT038 ; CDS983998C , Lot Number 24ABS145 ; CDS983998C , Lot Number 24BBO349 ; CDS983998C , Lot Number 20XBH030 ; CDS983998C , Lot Number 21ABJ573 ; CDS983998C , Lot Number 21ABM652 ; CDS983998C , Lot Number 21ABU323 ; CDS984018, Lot Number 21IBP644 ; CDS984018, Lot Number 21KBF278 ; CDS984018, Lot Number 21LBC606 ; CDS984018, Lot Number 22DBL432 ; CDS984018A , Lot Number 22HBI549 ; CDS984018A , Lot Number 22KBH985 ; CDS984018A , Lot Number 22KBK267 ; CDS984018A , Lot Number 22KBN675 ; CDS984018A , Lot Number 22LBC297 ; CDS984018A , Lot Number 23ABD419 ; CDS984018A , Lot Number 23BBA862 ; CDS984018A , Lot Number 23BBD101 ; CDS984018A , Lot Number 23DBA995 ; CDS984018A , Lot Number 23IBP739 ; CDS984018A , Lot Number 23IBT201 ; CDS984018A , Lot Number 23KBD214 ; CDS984018A , Lot Number 23KBM515 ; CDS984018A , Lot Number 24ABC270 ; CDS984018A , Lot Number 24BBT379 ; CDS984554B , Lot Number 21GBB824 ; CDS984554B , Lot Number 21GBW351 ; CDS984554B , Lot Number 21IBL028 ; CDS984554B , Lot Number 21KBK358 ; CDS984554B , Lot Number 22BBQ887 ; CDS984554B , Lot Number 22NBF722 ; CDS984554B , Lot Number 19BBC274 ; CDS984554B , Lot Number 22CBN646 ; CDS984554B , Lot Number 19CBL070 ; CDS984554B , Lot Number 22DBS802 ; CDS984554B , Lot Number 19DBY780 ; CDS984554B , Lot Number 22FBN743 ; CDS984554B , Lot Number 19EBZ008 ; CDS984554B , Lot Number 22GBM993 ; CDS984554B , Lot Number 22HBK775 ; CDS984554B , Lot Number 19GBS401 ; CDS984554B , Lot Number 22IBE787 ; CDS984554B , Lot Number 22LBA227 ; CDS984554B , Lot Number 19JBR640 ; CDS984554B , Lot Number 23ABQ942 ; CDS984554B , Lot Number 19KBA996 ; CDS984554B , Lot Number 23CBO820 ; CDS984554B , Lot Number 23DBN909 ; CDS984554B , Lot Number 20ABU816 ; CDS984554B , Lot Number 20BBW842 ; CDS984554B , Lot Number 23FBT548 ; CDS984554B , Lot Number 23GBO489 ; CDS984554B , Lot Number 20EBA029 ; CDS984554B , Lot Number 23IBG245 ; CDS984554B , Lot Number 20FBR042 ; CDS984554B , Lot Number 23KBC774 ; CDS984554B , Lot Number 23KBS497 ; CDS984554B , Lot Number 20HBG814 ; CDS984554B , Lot Number 20IBI238 ; CDS984554B , Lot Number 24ABI213 ; CDS984554B , Lot Number 20XBD355 ; CDS984554B , Lot Number 21BBB801 ; CDS984554B , Lot Number 21EBC891 ; CDS984616A , Lot Number 19ABW856 ; CDS984616A , Lot Number 19BBK938 ; CDS984616A , Lot Number 19CBG902 ; CDS984616A , Lot Number 19EBQ153 ; CDS984616A , Lot Number 19VBH323 ; CDS984616A , Lot Number 19WBA917 ; CDS984616A , Lot Number 20ABN426 ; CDS984616A , Lot Number 20HBP273 ; CDS984616A , Lot Number 20JBA630 ; CDS984616A , Lot Number 21ABE741 ; CDS984616A , Lot Number 21EBC437 ; CDS984768D , Lot Number 19BBN163 ; CDS984768D , Lot Number 19DBI271 ; CDS984768D , Lot Number 19EBB380 ; CDS984768D , Lot Number 19EBL850 ; CDS984768D , Lot Number 19RBD176 ; CDS984768D , Lot Number 19HBE331 ; CDS984768D , Lot Number 19HBN598 ; CDS984768D , Lot Number 19JBK970 ; CDS984768D , Lot Number 19KBI317 ; CDS984768D , Lot Number 20BBA087 ; CDS984768D , Lot Number 20BBU841 ; CDS984768D , Lot Number 20DBK998 ; CDS984768D , Lot Number 20FBC145 ; CDS984768D , Lot Number 20HBT178 ; CDS984768D , Lot Number 20IBP070 ; CDS984768D , Lot Number 20KBQ352 ; CDS984768F , Lot Number 21GBK429 ; CDS984768F , Lot Number 21JBK661 ; CDS984768F , Lot Number 22ABD944 ; CDS984768F , Lot Number 22ABV538 ; CDS984768F , Lot Number 22OBM389 ; CDS984768F , Lot Number 22FBM654 ; CDS984768F , Lot Number 22HBI594 ; CDS984768F , Lot Number 22IBN824 ; CDS984768F , Lot Number 22JBN646 ; CDS984768F , Lot Number 22KBH348 ; CDS984768F , Lot Number 22LBS201 ; CDS984768F , Lot Number 23ABQ871 ; CDS984768F , Lot Number 23BBB060 ; CDS984768F , Lot Number 23CBI633 ; CDS984768F , Lot Number 23GBG658 ; CDS984768F , Lot Number 23HBO466 ; CDS984768F , Lot Number 23HBW095 ; CDS984768F , Lot Number 23IBQ322 ; CDS984768F , Lot Number 23JBH916 ; CDS984768F , Lot Number 24ABS994 ; CDS984768F , Lot Number 21CBD973 ; CDS984768F , Lot Number 21EBK877 ; CDS984902G , Lot Number 19CBV237 ; CDS984902G , Lot Number 19EBP913 ; CDS984902G , Lot Number 19GBX030 ; CDS984902G , Lot Number 19IBF801 ; CDS984902G , Lot Number 19VBE265 ; CDS984902G , Lot Number 20ABP008 ; CDS984902G , Lot Number 20ABZ998 ; CDS984902G , Lot Number 20DBO117 ; CDS984902G , Lot Number 20EBO381 ; CDS984902G , Lot Number 20FBN392 ; CDS984902I , Lot Number 21GBF941 ; CDS984902I , Lot Number 21GBN253 ; CDS984902I , Lot Number 21HBV118 ; CDS984902I , Lot Number 20HBX394 ; CDS984902I , Lot Number 20JBX259 ; CDS984902I , Lot Number 21ABG480 ; CDS984902I , Lot Number 21CBK768 ; CDS984902I , Lot Number 21EBK909 ; CDS984902J , Lot Number 21JBE502 ; CDS984902J , Lot Number 21JBE504 ; CDS984902J , Lot Number 21LBB414 ; CDS984902J , Lot Number 22ABB388 ; CDS984902J , Lot Number 22ABB393 ; CDS984902J , Lot Number 22ABV542 ; CDS984902J , Lot Number 22DBN559 ; CDS984902J , Lot Number 22DBP428 ; CDS984902K , Lot Number 22IBL648 ; CDS984902K , Lot Number 22IBQ711 ; CDS984902K , Lot Number 22LBH577 ; CDS984902K , Lot Number 23ABM570 ; CDS984902K , Lot Number 23EBA169 ; CDS984902K , Lot Number 23GBJ635 ; CDS984902K , Lot Number 23HBU537 ; CDS984902K , Lot Number 23KBB878 ; CDS984902K , Lot Number 24ABD063 ; CDS984902K , Lot Number 24ABI595 ; CDS985206B , Lot Number 21FBM586 ; CDS985206B , Lot Number 21GBK432 ; CDS985206B , Lot Number 21KBK323 ; CDS985206B , Lot Number 21KBR557 ; CDS985206B , Lot Number 19ABY283 ; CDS985206B , Lot Number 19CBK527 ; CDS985206B , Lot Number 22DBQ786 ; CDS985206B , Lot Number 22DBS312 ; CDS985206B , Lot Number 19FBW674 ; CDS985206B , Lot Number 19FBZ073 ; CDS985206B , Lot Number 22HBN168 ; CDS985206B , Lot Number 22HBR869 ; CDS985206B , Lot Number 22JBL398 ; CDS985206B , Lot Number 19IBE430 ; CDS985206B , Lot Number 23ABQ305 ; CDS985206B , Lot Number 19KBC402 ; CDS985206B , Lot Number 19KBJ359 ; CDS985206B , Lot Number 23BBT108 ; CDS985206B , Lot Number 23CBI544 ; CDS985206B , Lot Number 19LBH074 ; CDS985206B , Lot Number 23DBH574 ; CDS985206B , Lot Number 20CBC192 ; CDS985206B , Lot Number 23HBI545 ; CDS985206B , Lot Number 20EBI688 ; CDS985206B , Lot Number 23IBP622 ; CDS985206B , Lot Number 20GBV104 ; CDS985206B , Lot Number 23LBV021 ; CDS985206B , Lot Number 20JBR074 ; CDS985206B , Lot Number 21ABJ566 ; CDS985206B , Lot Number 21CBE534 ; CDS985206B , Lot Number 21FBE180 ; CDS985257G , Lot Number 19CBG152 ; CDS985257G , Lot Number 19DBW455 ; CDS985257I , Lot Number 19FBY138 ; CDS985257I , Lot Number 19GBQ955 ; CDS985257I , Lot Number 19HBO232 ; CDS985257I , Lot Number 19IBC470 ; CDS985257I , Lot Number 19IBO719 ; CDS985257I , Lot Number 19IBP878 ; CDS985257I , Lot Number 19JBB120 ; CDS985257J , Lot Number 19LBU156 ; CDS985257J , Lot Number 20ABJ970 ; CDS985257J , Lot Number 20ABY030 ; CDS985257J , Lot Number 20DBK847 ; CDS985257J , Lot Number 20DBQ531 ; CDS985257J , Lot Number 20FBH150 ; CDS985257L , Lot Number 20HBE614 ; CDS985257L , Lot Number 20IBE822 ; CDS985257L , Lot Number 20JBR677 ; CDS985257L , Lot Number 20WBC596 ; CDS985257L , Lot Number 20LBI236 ; CDS985257L , Lot Number 21ABG841 ; CDS985257L , Lot Number 21CBL274 ; CDS985505G , Lot Number 23GBD611 ; CDS985505G , Lot Number 23HBK247 ; CDS985505G , Lot Number 23JBN811 ; CDS985505G , Lot Number 23JBN997 ; CDS985505G , Lot Number 23LBR417 ; CDS985505G , Lot Number 24ABB912 ; CDS985505G , Lot Number 24BBO519 ; CDS985560N , Lot Number 21FBN833 ; CDS985560N , Lot Number 21IBQ939 ; CDS985560N , Lot Number 21VBB443 ; CDS985560N , Lot Number 21VBB444 ; CDS985560N , Lot Number 21KBU616 ; CDS985560N , Lot Number 22MBA670 ; CDS985560N , Lot Number 22CBC829 ; CDS985560N , Lot Number 22FBR938 ; CDS985560N , Lot Number 22GBR798 ; CDS985560N , Lot Number 22IBO037 ; CDS985560N , Lot Number 23ABT065 ; CDS985560N , Lot Number 23GBJ214 ; CDS985560N , Lot Number 23JBO794 ; CDS985560N , Lot Number 24ABI346 ; CDS985560N , Lot Number 21CBD960 ; CDS985560N , Lot Number 21CBV972 ; CDS985560N , Lot Number 21EBA073 ; CDS985560N , Lot Number 21EBR807 ; CDSOBL122F , Lot Number 19BBP928 ; CDSOBL122F , Lot Number 19DBT672 ; CDSOBL122F , Lot Number 19EBT940 ; CDSOBL122F , Lot Number 19FBZ163 ; CDSOBL122G , Lot Number 21GBF970 ; CDSOBL122G , Lot Number 21JBF552 ; CDSOBL122G , Lot Number 21JBM252 ; CDSOBL122G , Lot Number 21JBQ495 ; CDSOBL122G , Lot Number 21VBA234 ; CDSOBL122G , Lot Number 19LBA512 ; CDSOBL122G , Lot Number 20ABN336 ; CDSOBL122G , Lot Number 20CBO953 ; CDSOBL122G , Lot Number 20DBB419 ; CDSOBL122G , Lot Number 20EBI852 ; CDSOBL122G , Lot Number 20FBP288 ; CDSOBL122G , Lot Number 20IBG251 ; CDSOBL122G , Lot Number 20KBB676 ; CDSOBL122G , Lot Number 21FBE338 ; CDSOBL122I , Lot Number 22ABE739 ; CDSOBL122J , Lot Number 22IBL694 ; CDSOBL122J , Lot Number 22KBN633 ; CDSOBL122J , Lot Number 22LBP098 ; CDSOBL122J , Lot Number 23ABH487 ; CDSOBL122J , Lot Number 23CBE977 ; CDSOBL122J , Lot Number 23CBV476 ; CDSOBL122J , Lot Number 23DBD857 ; CDSOBL122J , Lot Number 23FBD996 ; CDSOBL122K , Lot Number 23GBN153 ; CDSOBL122K , Lot Number 23GBV012 ; CDSOBL122K , Lot Number 23KBM376 ; CDSOBL122K , Lot Number 23LBA952 ; CDSOBL122K , Lot Number 24ABP964 ; CDSOBL122K , Lot Number 24BBO348 ; DM170B , Lot Number 19ABA545 ; DM170B , Lot Number 19ABO769 ; DM170B , Lot Number 19CBG586 ; DM170B , Lot Number 19DBH019 ; DM170B , Lot Number 19EBY818 ; DM170B , Lot Number 19RBB716 ; DM170B , Lot Number 19HBE086 ; DM170B , Lot Number 19TBA994 ; DM170B , Lot Number 19IBV795 ; DYNJ00030N , Lot Number 21HBN111 ; DYNJ00030N , Lot Number 21IBQ363 ; DYNJ00030N , Lot Number 21KBW256 ; DYNJ00030N , Lot Number 22ABK304 ; DYNJ00030N , Lot Number 19BBC739 ; DYNJ00030N , Lot Number 22OBA600 ; DYNJ00030N , Lot Number 19CBD461 ; DYNJ00030N , Lot Number 22OBF887 ; DYNJ00030N , Lot Number 22EBP308 ; DYNJ00030N , Lot Number 19EBJ491 ; DYNJ00030N , Lot Number 22GBJ928 ; DYNJ00030N , Lot

Distribution pattern

Worldwide distribution.

device · product 69 of 81

Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ; 10) LAVH CDS, Pack Number CDS920130K ; 11) LAVH PROCEDURE, Pack Number CDS980754R ; 12) LAVH PROCEDURE, Pack Number CDS980754S ; 13) VAG HYST KIT, Pack Number CDS981313L ; 14) VAG HYST KIT, Pack Number CDS981313M ; 15) MINOR LITHOTOMY , Pack Number CDS982037W ; 16) MAJOR LITHOTOMY , Pack Number CDS982052V ; 17) D&C CDS , Pack Number CDS982061K ; 18) LAVH, Pack Number CDS982273Q ; 19) LAVH, Pack Number CDS982273R ; 20) LAVH, Pack Number CDS982273S ; 21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ; 22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ; 23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ; 24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ; 25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ; 26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ; 27) VAGINAL MAJOR , Pack Number CDS982689S ; 28) VAGINAL MAJOR , Pack Number CDS982689T ; 29) GYN/ABDOMINAL , Pack Number CDS982725K ; 30) GYN/ABDOMINAL , Pack Number CDS982725N ; 31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ; 32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ; 33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ; 34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ; 35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ; 36) CUH LITHOTOMY CDS , Pack Number CDS983207M ; 37) CUH LITHOTOMY CDS , Pack Number CDS983207N ; 38) VAGINAL MINOR , Pack Number CDS983268I ; 39) LAVH CDS, Pack Number CDS983411I ; 40) LAVH CDS, Pack Number CDS983411J ; 41) LAVH CDS, Pack Number CDS983411K ; 42) LAVH PROCEDURE, Pack Number CDS983449L ; 43) LAVH PROCEDURE, Pack Number CDS983449M ; 44) LAVH PROCEDURE, Pack Number CDS983449N ; 45) LAVH CDS, Pack Number CDS983455C ; 46) MAJOR VAGINAL , Pack Number CDS983497J ; 47) MAJOR VAGINAL , Pack Number CDS983497L ; 48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ; 49) VAG HYST CDS, Pack Number CDS983697J ; 50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ; 51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ; 52) GYN MINOR CDS , Pack Number CDS983985G ; 53) GYN ABDOMINAL CDS , Pack Number CDS983988A ; 54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ; 55) TVT CDS , Pack Number CDS984091J ; 56) GROTH VAGINAL CDS , Pack Number CDS984201T ; 57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ; 58) GYN CDS , Pack Number CDS984676C ; 59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304; 60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ; 61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ; 62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ; 63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ; 64) MAJOR LITHOTOMY , Pack Number CDS985547N ; 65) PROCEDURE TRAY, Pack Number DYNDA2966; 66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ; 67) TVH TRAY, Pack Number DYNJ00460L ; 68) TVH TRAY, Pack Number DYNJ00460M ; 69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ; 70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ; 71) LAVH PACK-LF, Pack Number DYNJ00470K ; 72) LAVH PACK-LF, Pack Number DYNJ00470L ; 73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ; 74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ; 75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ; 76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ; 77) LAVH PACK-LF, Pack Number DYNJ0372824Q ; 78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ; 79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ; 80) VAGINAL HYSTERECTOMY PACK-

Z-3049-2024
Recall number
Z-3049-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

C040100, Lot Number 19BDB794 ; C040100, Lot Number 19BDB938 ; C040100, Lot Number 19CDD009 ; C040100, Lot Number 19EDC262 ; C040100, Lot Number 19EDC533 ; C040100, Lot Number 19JDA569 ; C040100, Lot Number 19JDA836 ; C040100, Lot Number 19JDC293 ; C040100, Lot Number 19LDB582 ; C040100, Lot Number 20BDA227 ; C040100, Lot Number 20BDA828 ; C040100, Lot Number 20BDC639 ; C040100, Lot Number 20DDA503 ; C040100, Lot Number 20DDA627 ; C040100, Lot Number 20HDC033 ; C040100, Lot Number 21HDA277 ; C040100, Lot Number 22EDB968 ; C040100, Lot Number 22HDB951 ; CDS760049AD, Lot Number 21IBC904 ; CDS760049AD, Lot Number 21IBM329 ; CDS760049AD, Lot Number 21LBS989 ; CDS760049AD, Lot Number 22CBW119 ; CDS760049AD, Lot Number 22OBL416 ; CDS760049AD, Lot Number 22OBL970 ; CDS760049AD, Lot Number 22GBD274 ; CDS760049AD, Lot Number 22IBF092 ; CDS760049AD, Lot Number 22JBF094 ; CDS760049AD, Lot Number 22KBF472 ; CDS760049AD, Lot Number 22KBI850 ; CDS760049AD, Lot Number 23ABF834 ; CDS760049AD, Lot Number 23BBK772 ; CDS760049AD, Lot Number 23CBT560 ; CDS760049AD, Lot Number 23EBO959 ; CDS760049AD, Lot Number 23GBP399 ; CDS760049AD, Lot Number 23GBT911 ; CDS760049AD, Lot Number 23IBQ689 ; CDS760049AD, Lot Number 23JBI109 ; CDS760049AD, Lot Number 23KBD213 ; CDS760049AF, Lot Number 23LBV054 ; CDS760049AF, Lot Number 24ABR231 ; CDS760056G , Lot Number 22BBZ815 ; CDS760056G , Lot Number 22OBM631 ; CDS760056G , Lot Number 22JBI460 ; CDS760056G , Lot Number 23ABP479 ; CDS760056G , Lot Number 23FBG175 ; CDS760056G , Lot Number 23HBA191 ; CDS760056G , Lot Number 23IBP582 ; CDS760056G , Lot Number 23KBL445 ; CDS760056G , Lot Number 23KBP697 ; CDS760056G , Lot Number 24BBQ489 ; CDS760088Q , Lot Number 19CBG116 ; CDS760088Q , Lot Number 19DBG523 ; CDS760088R , Lot Number 21GBS618 ; CDS760088R , Lot Number 21HBB248 ; CDS760088R , Lot Number 21IBP890 ; CDS760088R , Lot Number 22OBM585 ; CDS760088R , Lot Number 19UBA526 ; CDS760088R , Lot Number 19JBX112 ; CDS760088R , Lot Number 19VBB261 ; CDS760088R , Lot Number 20BBZ171 ; CDS760088R , Lot Number 20GBU569 ; CDS760088R , Lot Number 20IBO653 ; CDS760088R , Lot Number 20KBS815 ; CDS760088R , Lot Number 20XBH134 ; CDS760088S , Lot Number 22HMG145 ; CDS760088S , Lot Number 22IMA901 ; CDS760088S , Lot Number 22JMG651 ; CDS830186P , Lot Number 22CBP266 ; CDS830186P , Lot Number 22DBK431 ; CDS830186P , Lot Number 22DBL618 ; CDS830186R , Lot Number 22FBR813 ; CDS830186R , Lot Number 22HBD852 ; CDS830186R , Lot Number 22IBA199 ; CDS920130K , Lot Number 23HME492 ; CDS920130K , Lot Number 23HME823 ; CDS920130K , Lot Number 23HMH121 ; CDS920130K , Lot Number 23IMF884 ; CDS980754R , Lot Number 23BMB975 ; CDS980754R , Lot Number 23BMC711 ; CDS980754S , Lot Number 23KMC281 ; CDS980754S , Lot Number 23KMG518 ; CDS980754S , Lot Number 23LMH962 ; CDS980754S , Lot Number 24AMG691 ; CDS980754S , Lot Number 24BMC635 ; CDS981313L , Lot Number 19ABX762 ; CDS981313L , Lot Number 19DBA731 ; CDS981313L , Lot Number 19EBY373 ; CDS981313L , Lot Number 19HBI633 ; CDS981313L , Lot Number 19JBT845 ; 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DYNJ0209066N , Lot Number 19LBX094 ; DYNJ0209066N , Lot Number 20FBC251 ; DYNJ0209066N , Lot Number 20GBA458 ; DYNJ0209066N , Lot Number 20HMD240 ; DYNJ0209066N , Lot Number 20JMC237 ; DYNJ0209066N , Lot Number 20JMD994 ; DYNJ0209066N , Lot Number 21BMB538 ; DYNJ0209066N , Lot Number 21FMF370 ; DYNJ0209066N , Lot Number 21LMA664 ; DYNJ0209066N , Lot Number 22AMA527 ; DYNJ0209066N , Lot Number 22BMC183 ; DYNJ0209066N , Lot Number 22CME713 ; DYNJ0209066N , Lot Number 22EMD966 ; DYNJ0209066N , Lot Number 22FMH195 ; DYNJ0209066N , Lot Number 22GMH896 ; DYNJ0209066N , Lot Number 22JME324 ; DYNJ0209066N , Lot Number 22LMF262 ; DYNJ0209066N , Lot Number 23DMD835 ; DYNJ0209066N , Lot Number 23EMG822 ; DYNJ0209066N , Lot Number 23FMA868 ; DYNJ0209066N , Lot Number 23GMD713 ; DYNJ0209066N , Lot Number 23HMC404 ; DYNJ0209066N , Lot Number 23KMA076 ; DYNJ0209066N , Lot Number 19BKD644 ; DYNJ0362432P , Lot Number 21KBP347 ; DYNJ0362432P , Lot Number 22BBG379 ; DYNJ0362432P , Lot Number 22BBT772 ; DYNJ0362432P , Lot Number 22AMD156 ; DYNJ0362432P , Lot Number 22FMF412 ; DYNJ0362432P , Lot Number 22GMC959 ; DYNJ0362432P , Lot Number 22JMB703 ; DYNJ0362432P , Lot Number 22KMC176 ; DYNJ0362432P , Lot Number 23AMF343 ; DYNJ0362432P , Lot Number 23CMB451 ; DYNJ0362432P , Lot Number 23DMD796 ; DYNJ0362432P , Lot Number 23FMB208 ; DYNJ0362432P , Lot Number 23HMF487 ; DYNJ0362432P , Lot Number 23IMG099 ; DYNJ0362432P , Lot Number 23JMF347 ; DYNJ0362432P , Lot Number 23KMB662 ; DYNJ0362432P , Lot Number 23LME328 ; DYNJ0362432P , Lot Number 24AMC028 ; DYNJ0372824Q , Lot Number 21IBD088 ; DYNJ0372824Q , Lot Number 21JBF240 ; DYNJ0372824Q , Lot Number 22ABT072 ; DYNJ0372824Q , Lot Number 22EBC902 ; DYNJ0372824Q , Lot Number 22IBV268 ; DYNJ0372824Q , Lot Number 23BBH580 ; DYNJ0372824Q , Lot Number 23CBH736 ; DYNJ0372824Q , Lot Number 23GBW520 ; DYNJ0372824Q , Lot Number 23HBY739 ; DYNJ0372824Q , Lot Number 23KBW828 ; DYNJ0372824Q , Lot Number 23LBR339 ; DYNJ0373807I , Lot Number 19ABC254 ; DYNJ0373807I , Lot Number 19DBB039 ; DYNJ0373807I , Lot Number 19GBD310 ; DYNJ0373807I , Lot Number 19KBG862 ; DYNJ0373807I , Lot Number 19LBA756 ; DYNJ0373807I , Lot Number 19LBY693 ; DYNJ0373807I , Lot Number 20DBI304 ; DYNJ0373807J , Lot Number 21HBP832 ; DYNJ0373807J , Lot Number 21IBP757 ; DYNJ0373807J , Lot Number 22ABH525 ; DYNJ0373807J , Lot Number 22EBC904 ; DYNJ0373807K , Lot Number 22HBV873 ; DYNJ0373807K , Lot Number 22JBO175 ; DYNJ0378319J , Lot Number 19ABF155 ; DYNJ0378319J , Lot Number 19ABX344 ; DYNJ0381389G , Lot Number 19BKC500 ; DYNJ0381389G , Lot Number 19DKA746 ; DYNJ0381389G , Lot Number 19DKA785 ; DYNJ0381389G , Lot Number 19GKB094 ; DYNJ0386268P , Lot Number 20GMB938 ; DYNJ0386268P , Lot Number 20IMD772 ; DYNJ0386268P , Lot Number 21DMA282 ; DYNJ0386268P , Lot Number 21DME423 ; DYNJ0386268P , Lot Number 21GMC090 ; DYNJ0386268P , Lot Number 21JMG877 ; DYNJ0386268Q , Lot Number 21KME902 ; DYNJ0386268Q , Lot Number 22CMF982 ; DYNJ0386268Q , Lot Number 22EME980 ; DYNJ0386268Q , Lot Number 22IMD397 ; DYNJ0386268Q , Lot Number 22LMB324 ; DYNJ0386268Q , Lot Number 23DMH845 ; DYNJ0386268Q , Lot Number 23GMD866 ; DYNJ0386268Q , Lot Number 23KMC901 ; DYNJ0415760O , Lot Number 20KMC998 ; DYNJ0415760O , Lot Number 21BMC219 ; DYNJ0415760O , Lot Number 21EME847 ; DYNJ0415760O , Lot Number 21FME803 ; DYNJ0415760O , Lot Number 21GMD590 ; DYNJ0415760O , Lot Number 21IMF889 ; DYNJ0415760O , Lot Number 21LMF717 ; DYNJ0415760O , Lot Number 22BMB830 ; DYNJ0415760O , Lot Number 22FMB785 ; DYNJ0415760O , Lot Number 22HMG347 ; DYNJ0415760O , Lot Number 22JMH873 ; DYNJ0415760O , Lot Number 23BMG967 ; DYNJ0415760O , Lot Number 23DMB532 ; DYNJ0415760O , Lot Number 23FMA226 ; DYNJ0415760O , Lot Number 23HMH707 ; DYNJ0415760O , Lot Number 23IMG049 ; DYNJ0415760O , Lot Number 23JMC003 ; DYNJ0415941I , Lot Number 19AKD285 ; DYNJ0415941I , Lot Number 19CKD631 ; DYNJ0415941I , Lot Number 19EKC543 ; DYNJ0415941I , Lot Number 19GKB045 ; DYNJ0416529R , Lot Number 19BBF220 ; DYNJ0416529R , Lot Number 19CBG029 ; DYNJ0416529R , Lot Number 19CBN259 ; DYNJ0416529R , Lot Number 19QBC234 ; DYNJ0416529R , Lot Number 19TBC130 ; DYNJ0416529V , Lot Number 21GBH153 ; DYNJ0416529V , Lot Number 21GBS970 ; DYNJ0416529V , Lot Number 21HBM359 ; DYNJ0416529V , Lot Number 21JBW225 ; DYNJ0416529V , Lot Number 22DBG622 ; DYNJ0416529V , Lot Number 22LBQ458 ; DYNJ0416529V , Lot Number 21DBW409 ; DYNJ0416529V , Lot Number 21EBF296 ; DYNJ0416529W , Lot Number 23CBB975 ; DYNJ0416529W , Lot Number 23FBQ639 ; DYNJ0416529W , Lot Number 23HBM997 ; DYNJ0416529W , Lot Number 23JBK763 ; DYNJ0416529W , Lot Number 23KBI381 ; DYNJ0425778L , Lot Number 21HBB424 ; DYNJ0425778M , Lot Number 22FMC747 ; DYNJ0425778M , Lot Number 22HMH702 ; DYNJ0425778M , Lot Number 22IMH817 ; DYNJ0425778M , Lot Number 23AMG986 ; DYNJ0425778M , Lot Number 23AMI251 ; DYNJ0425778M , Lot Number 23CMD844 ; DYNJ0425778M , Lot Number 23DMF717 ; DYNJ0425778M , Lot Number 23EMD230 ; DYNJ0425778M , Lot Number 23FMF089 ; DYNJ0425778M , Lot Number 23GMG780 ; DYNJ0425778M , Lot Number 23IME073 ; DYNJ0425778M , Lot Number 23JMB733 ; DYNJ0425778M , Lot Number 21KLB153 ; DYNJ0425778M , Lot Number 21LLA348 ; DYNJ0425778M , Lot Number 22BLA746 ; DYNJ0425778M , Lot Number 22BLB130 ; DYNJ0425778M , Lot Number 22CLA896 ; DYNJ0425778M , Lot Number 22DLB089 ; DYNJ04691R , Lot Number 23DMI418 ; DYNJ04691R , Lot Number 23FMJ033 ; DYNJ04691R , Lot Number 23HMA043 ; DYNJ04691R , Lot Number 23IMF726 ; DYNJ04691R , Lot Number 23IMG335 ; DYNJ04840P , Lot Number 23HMA594 ; DYNJ04840P , Lot Number 23HME117 ; DYNJ0532873L , Lot Number 21IMG118 ; DYNJ0532873M , Lot Number 22FMH645 ; DYNJ0532873M , Lot Number 22GMG335 ; DYNJ0532873M , Lot Number 22HMF692 ; DYNJ0532873N , Lot Number 23DMD053 ; DYNJ0537688AJ, Lot Number 21IMC191 ; DYNJ0537688AK, Lot Number 21LMC572 ; DYNJ0537688AK, Lot Number 22BME495 ; DYNJ0537688AK, Lot Number 22CMC314 ; DYNJ0537688AK, Lot Number 22EMF228 ; DYNJ0537688AK, Lot Number 22FMA707 ; DYNJ0537688AK, Lot Number 22IMC902 ; DYNJ0537688AK, Lot Number 22JMH184 ; DYNJ0537688AK, Lot Number 23AMI379 ; DYNJ0537688AK, Lot Number 23CMA399 ; DYNJ0537688AK, Lot Number 23EMF818 ; DYNJ0537688AK, Lot Number 23FMI973 ; DYNJ0537688AK, Lot Number 23GMI233 ; DYNJ0537688AK, Lot Number 23IMF258 ; DYNJ0537688AK, Lot Number 23JMJ374 ; DYNJ0537688AK, Lot Number 23KMG879 ; DYNJ0537688AK, Lot Number 23LMG034 ; DYNJ0547084L , Lot Number 19AKD146 ; DYNJ0547084L , Lot Number 19CKB258 ; DYNJ0547084L , Lot Number 19EKC623 ; DYNJ0547084O , Lot Number 21EMD315 ; DYNJ0547084O , Lot Number 21FMB952 ; DYNJ0547084O , Lot Number 21GMB909 ; DYNJ0547084O , Lot Number 21HMA371 ; DYNJ0547084O , Lot Number 21HME779 ; DYNJ0547084O , Lot Number 21JMD912 ; DYNJ0547084O , Lot Number 22AMC898 ; DYNJ0547084O , Lot Number 22CMF119 ; DYNJ0547084O , Lot Number 22FMB324 ; DYNJ0547084O , Lot Number 22KMB706 ; DYNJ0547084O , Lot Number 22LMJ300 ; DYNJ0547084O , Lot Number 23CMC442 ; DYNJ0547084O , Lot Number 23DMG212 ; DYNJ0547084O , Lot Number 23FMD877 ; DYNJ0547084O , Lot Number 23HMC128 ; DYNJ0547084O , Lot Number 23KME941 ; DYNJ0549338P , Lot Number 19EBP202 ; DYNJ0549338P , Lot Number 19HBJ318 ; DYNJ0549338P , Lot Number 19IBZ196 ; DYNJ0549338P , Lot Number 19VBB543 ; DYNJ0549338P , Lot Number 19KBZ332 ; DYNJ0549338P , Lot Number 20CBV163 ; DYNJ0549338P , Lot Number 20IMC699 ; DYNJ0549338P , Lot Number 20JME852 ; DYNJ0549338P , Lot Number 21AMC109 ; DYNJ0549338P , Lot Number 21DMD917 ; DYNJ0549338P , Lot Number 21FMA594 ; DYNJ0549338P , Lot Number 21GMB569 ; DYNJ0549338P , Lot Number 21IMB941 ; DYNJ0549338P , Lot Number 21KMH919 ; DYNJ0549338P , Lot Number 19AKD619 ; DYNJ0549338P , Lot Number 19CKC615 ; DYNJ0549338Q , Lot Number 22AME260 ; DYNJ0549338Q , Lot Number 22BMA078 ; DYNJ0549338Q , Lot Number 22CMD353 ; DYNJ0549338Q , Lot Number 22DME990 ; DYNJ0549338Q , Lot Number 22GMF448 ; DYNJ0549338Q , Lot Number 22HME393 ; DYNJ0549338Q , Lot Number 22KMD553 ; DYNJ0549338Q , Lot Number 22LMF900 ; DYNJ0549338Q , Lot Number 23AMF896 ; DYNJ0549338Q , Lot Number 23CMA819 ; DYNJ0549338Q , Lot Number 23DME381 ; DYNJ0549338Q , Lot Number 23EMD924 ; DYNJ0549338R , Lot Number 23FMG142 ; DYNJ0549338R , Lot Number 23HMD655 ; DYNJ0549338R , Lot Number 23JMG106 ; DYNJ0565537P , Lot Number 18LBN971 ; DYNJ0565537P , Lot Number 19ABP800 ; DYNJ0565537P , Lot Number 19BBR938 ; DYNJ0565537P , Lot Number 19FBG872 ; DYNJ0565537P , Lot Number 19GBS081 ; DYNJ0565543T , Lot Number 21GMB444 ; DYNJ0565543T , Lot Number 21HMG874 ; DYNJ0565543T , Lot Number 21IMG019 ; DYNJ0565543T , Lot Number 21JMC883 ; DYNJ0565543T , Lot Number 21JME321 ; DYNJ0565543T , Lot Number 21LME868 ; DYNJ0565543T , Lot Number 22AMD950 ; DYNJ0565543T , Lot Number 22BMF057 ; DYNJ0565543T , Lot Number 22CMJ026 ; DYNJ0565543T , Lot Number 22EMF502 ; DYNJ0565543T , Lot Number 22FMG518 ; DYNJ0565543T , Lot Number 22IMC903 ; DYNJ0565543T , Lot Number 22JMC082 ; DYNJ0565543T , Lot Number 22LMC782 ; DYNJ0565543T , Lot Number 23AMA802 ; DYNJ0565543T , Lot Number 23CMC206 ; DYNJ0565543T , Lot Number 23EMA571 ; DYNJ0565543T , Lot Number 23EMG752 ; DYNJ0565543T , Lot Number 23FME852 ; DYNJ0597304L , Lot Number 20GMB814 ; DYNJ0597304L , Lot Number 20GMC612 ; DYNJ0597304L , Lot Number 20IMC059 ; DYNJ0597304L , Lot Number 20LMC228 ; DYNJ0597304L , Lot Number 21IMH102 ; DYNJ0597304L , Lot Number 22AMD735 ; DYNJ0597304L , Lot Number 22AMG030 ; DYNJ0597304L , Lot Number 22GMH822 ; DYNJ0597304L , Lot Number 22KMC193 ; DYNJ0597304L , Lot Number 23BMH400 ; DYNJ0597304L , Lot Number 23GME300 ; DYNJ0665086F , Lot Number 21IBG229 ; DYNJ0665086F , Lot Number 21LBG696 ; DYNJ0665086F , Lot Number 22ABJ222 ; DYNJ0665086F , Lot Number 22DBK166 ; DYNJ0665086F , Lot Number 22EBG377 ; DYNJ0665086F , Lot Number 22FBJ595 ; DYNJ0665086F , Lot Number 22IBT460 ; DYNJ0665086F , Lot Number 22LBQ460 ; DYNJ0665086F , Lot Number 23BBI587 ; DYNJ0665086F , Lot Number 23DBJ034 ; DYNJ0665086F , Lot Number 23EBP148 ; DYNJ0665086F , Lot Number 23GBS960 ; DYNJ0665086F , Lot Number 23IBC521 ; DYNJ0665086F , Lot Number 23IBU386 ; DYNJ0665086F , Lot Number 23JBW085 ; DYNJ0665086F , Lot Number 20KBK990 ; DYNJ0665086F , Lot Number 20XBC194 ; DYNJ0665086F , Lot Number 20XBG915 ; DYNJ0665086F , Lot Number 21CBX234 ; DYNJ0665086G , Lot Number 23LBA535 ; DYNJ0665427D , Lot Number 19ABN671 ; DYNJ0665427D , Lot Number 19DBR158 ; DYNJ0665427D , Lot Number 19RBC395 ; DYNJ0665427D , Lot Number 19IBD701 ; DYNJ0665427D , Lot Number 19KBF018 ; DYNJ0665427D , Lot Number 20ABT374 ; DYNJ0665427D , Lot Number 20BBV459 ; DYNJ0665427D , Lot Number 20DBS488 ; DYNJ0665427F , Lot Number 21IBU033 ; DYNJ0665427F , Lot Number 21KBD788 ; DYNJ0665427F , Lot Number 22ABA612 ; DYNJ0665427F , Lot Number 22EBI819 ; DYNJ0665427F , Lot Number 23ABM288 ; DYNJ0665427F , Lot Number 23EBU598 ; DYNJ0665427F , Lot Number 23GBI799 ; DYNJ0665427F , Lot Number 23HBA968 ; DYNJ0665427F , Lot Number 23JBJ762 ; DYNJ0665427F , Lot Number 20LBO555 ; DYNJ0665427F , Lot Number 20LBR905 ; DYNJ0665427F , Lot Number 21BBE572 ; DYNJ0665427F , Lot Number 21CBX245 ; DYNJ0665427G , Lot Number 23KBS318 ; DYNJ0705988J , Lot Number 23EMJ179 ; DYNJ0705988J , Lot Number 23HMD657 ; DYNJ0750737P , Lot Number 21JMA356 ; DYNJ0750737P , Lot Number 22AMA386 ; DYNJ0750737P , Lot Number 22BME445 ; DYNJ0750737P , Lot Number 22BMH105 ; DYNJ0750737P , Lot Number 22CMF097 ; DYNJ0750737Q , Lot Number 23DMF402 ; DY

Distribution pattern

Worldwide distribution.

device · product 70 of 81

Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6) ROBOTIC CDS , Pack Number CDS981882Q ; 7) ROBOTIC CDS , Pack Number CDS981882R ; 8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ; 9) D&C CDS-WRMC, Pack Number CDS982331N ; 10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ; 11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ; 12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ; 13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ; 14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ; 15) GYN/ABDOMINAL , Pack Number CDS982725M ; 16) ROBOTIC CDS , Pack Number CDS982888D ; 17) ROBOTIC CDS , Pack Number CDS982888F ; 18) ROBOTIC CDS , Pack Number CDS982888G ; 19) ROBOTIC CDS , Pack Number CDS983028D ; 20) ZALE PUMP CDS , Pack Number CDS983187F ; 21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ; 22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ; 23) ROBOTIC CDS-LF, Pack Number CDS983258O ; 24) ROBOTIC CDS-LF, Pack Number CDS983258Q ; 25) VAGINAL MINOR , Pack Number CDS983268K ; 26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ; 27) ROBOTIC CDS , Pack Number CDS983399D ; 28) GYN VAGINAL CDS , Pack Number CDS983528L ; 29) GYN VAGINAL CDS , Pack Number CDS983528M ; 30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ; 31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ; 32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ; 33) OB CDS, Pack Number CDS983854B ; 34) OB/GYN CDS, Pack Number CDS984173F ; 35) GROTH VAGINAL , Pack Number CDS984201V ; 36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ; 37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ; 38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ; 39) GYN CDS , Pack Number CDS984860G ; 40) OB DELIVERY CDS , Pack Number CDS985027I ; 41) OB/GYN CDS RICE , Pack Number CDS985256C ; 42) OB/GYN CDS RICE , Pack Number CDS985256D ; 43) OB/GYN CDS RICE , Pack Number CDS985256F ; 44) OB CDS-LF , Pack Number CDS985320C ; 45) OB, Pack Number CDS985506D ; 46) OB, Pack Number CDS985506F ; 47) OB, Pack Number CDS985506G ; 48) OB, Pack Number CDS985506I ; 49) GYN LAPAROSCOPY , Pack Number CDS985519L ; 50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ; 51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ; 52) PERI-GYN PACK-LF, Pack Number DYNJ0038057; 53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ; 54) DAVINCI PACK-LF , Pack Number DYNJ0042750; 55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ; 56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ; 57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ; 58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ; 59) D AND C PACK-LF , Pack Number DYNJ0161028C ; 60) D AND C PACK-LF , Pack Number DYNJ0161028F ; 61) D AND C PACK-LF , Pack Number DYNJ0161028G ; 62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ; 63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ; 64) ROBOT PACK, Pack Number DYNJ01823F ; 65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ; 66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ; 67) OB PACK , Pack Number DYNJ03387A ; 68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ; 69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ; 70) OB PACK-LF, Pack Number DYNJ0367126L ; 71) OB PACK-LF, Pack Number DYNJ0367126M ; 72) OB PACK-LF, Pack Number DYNJ0367126N ; 73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ; 74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ; 75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ; 76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ; 77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ; 78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ; 79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ; 80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ; 81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ

Z-3050-2024
Recall number
Z-3050-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS830039AD, Lot Number 19CBH292 ; CDS830039AD, Lot Number 19PBC608 ; CDS840214P , Lot Number 21FBN852 ; CDS840214P , Lot Number 21HBB376 ; CDS840214P , Lot Number 21HBF491 ; CDS840214P , Lot Number 21IBO111 ; CDS840214P , Lot Number 22ABD314 ; CDS840214P , Lot Number 22BBI956 ; CDS840214P , Lot Number 22HBP289 ; CDS840214P , Lot Number 22IBO308 ; CDS840214P , Lot Number 22IBR971 ; CDS840214P , Lot Number 22KBN497 ; CDS840214P , Lot Number 20JBQ048 ; CDS840214P , Lot Number 20KBG189 ; CDS840214P , Lot Number 20KBY177 ; CDS840214P , Lot Number 21BBC946 ; CDS981335C , Lot Number 21GBL170 ; CDS981335C , Lot Number 21HBB530 ; CDS981335C , Lot Number 21WBA896 ; CDS981335C , Lot Number 22NBC853 ; CDS981335C , Lot Number 22OBB104 ; CDS981335C , Lot Number 22IBP869 ; CDS981335C , Lot Number 20GBI170 ; CDS981335C , Lot Number 20KBR144 ; CDS981335C , Lot Number 21BBE035 ; CDS981335C , Lot Number 21BBL646 ; CDS981335C , Lot Number 21EBH220 ; CDS981757P , Lot Number 21FMB526 ; CDS981757P , Lot Number 21FMD778 ; 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CDS985256D , Lot Number 19HBM987 ; CDS985256F , Lot Number 19JBL693 ; CDS985320C , Lot Number 21FBK807 ; CDS985320C , Lot Number 21GBC653 ; CDS985320C , Lot Number 21GBC654 ; CDS985320C , Lot Number 21IBE908 ; CDS985320C , Lot Number 21IBE909 ; CDS985320C , Lot Number 19DBV869 ; CDS985320C , Lot Number 19FBB572 ; CDS985320C , Lot Number 19GBF783 ; CDS985320C , Lot Number 19SBB108 ; CDS985320C , Lot Number 19IBC999 ; CDS985320C , Lot Number 19JBT205 ; CDS985320C , Lot Number 20FBE575 ; CDS985320C , Lot Number 20GBI686 ; CDS985320C , Lot Number 20GBW046 ; CDS985320C , Lot Number 20KBX660 ; CDS985320C , Lot Number 21DBP506 ; CDS985320C , Lot Number 21EBB796 ; CDS985320C , Lot Number 21EBN251 ; CDS985506D , Lot Number 19ABH662 ; CDS985506D , Lot Number 19CBF233 ; CDS985506D , Lot Number 19EBA644 ; CDS985506D , Lot Number 19EBR979 ; CDS985506F , Lot Number 19GBO317 ; CDS985506F , Lot Number 19HBU762 ; CDS985506F , Lot Number 19IBI149 ; CDS985506F , Lot Number 19IBY170 ; CDS985506F , Lot Number 19KBT637 ; CDS985506G , Lot Number 20ALA516 ; CDS985506G , Lot Number 20CLA011 ; CDS985506G , Lot Number 20CLA547 ; CDS985506I , Lot Number 20ELA172 ; CDS985506I , Lot Number 20FLA154 ; CDS985506I , Lot Number 20GLA684 ; CDS985506I , Lot Number 20HLA686 ; CDS985506I , Lot Number 20ILA314 ; CDS985506I , Lot Number 20JLA186 ; CDS985506I , Lot Number 20KLA103 ; CDS985506I , Lot Number 20KLA595 ; CDS985506I , Lot Number 21ALA616 ; CDS985506I , Lot Number 21BLA603 ; CDS985506I , Lot Number 21CLA632 ; CDS985506I , Lot Number 21DLA134 ; CDS985506I , Lot Number 21FLA242 ; CDS985506I , Lot Number 21GLA834 ; CDS985506I , Lot Number 21HLA369 ; CDS985506I , Lot Number 21ILA510 ; CDS985506I , Lot Number 21ILA858 ; CDS985506I , Lot Number 21JLA314 ; CDS985506I , Lot Number 21LLA050 ; CDS985506I , Lot Number 22BLB078 ; CDS985519L , Lot Number 22KBT778 ; CDS985519L , Lot Number 22LBB072 ; CDS985519L , Lot Number 23ABA018 ; CDS985519L , Lot Number 23BBU178 ; CDS985519L , Lot Number 23EBR445 ; CDS985519L , Lot Number 23FBH002 ; CDS985519L , Lot Number 23GBM759 ; CDS985519L , Lot Number 23HBJ261 ; CDS985519L , Lot Number 23HBN220 ; CDS985519L , Lot Number 23IBJ290 ; CDS985519L , Lot Number 23KBS460 ; CDS985519L , Lot Number 24ABO338 ; CDS985519L , Lot Number 24CBG079 ; DYKMBNDL109A , Lot Number 21IBS290 ; DYNDE1010A , Lot Number 21LBK999 ; DYNDE1010A , Lot Number 19KBY584 ; DYNDE1010A , Lot Number 19LBG988 ; DYNDE1010A , Lot Number 20ABE241 ; DYNDE1010A , Lot Number 20IBD616 ; DYNDE1010A , Lot Number 20IBI215 ; DYNDE1010A , Lot Number 22CMD790 ; DYNDE1010A , Lot Number 22EMI322 ; DYNDE1010A , Lot Number 23GME565 ; DYNDE1010A , Lot Number 23HMA476 ; DYNDE1010A , Lot Number 23IMB500 ; DYNJ0038057, Lot Number 19ABT007 ; DYNJ0038057, Lot Number 19EBR948 ; DYNJ0038057, Lot Number 19GBQ617 ; DYNJ0038057, Lot Number 19HBZ520 ; DYNJ0038057, Lot Number 19JBA780 ; DYNJ0038057, Lot Number 19KBO150 ; DYNJ0038057, Lot Number 20BBC846 ; DYNJ0038057, Lot Number 20DBR645 ; DYNJ0038057, Lot Number 20FBU132 ; DYNJ0038057, Lot Number 20HBI961 ; DYNJ0038057, Lot Number 20IBK385 ; DYNJ0038057, Lot Number 21EBN590 ; DYNJ0038057, Lot Number 21GMC138 ; DYNJ0038057, Lot Number 21HMF720 ; DYNJ0038057, Lot Number 21JMA187 ; DYNJ0038057, Lot Number 21KMB720 ; DYNJ0038057, Lot Number 21KMG669 ; DYNJ0038057, Lot Number 22AMD848 ; DYNJ0038057, Lot Number 22EMF483 ; DYNJ0038258B , Lot Number 21FBU162 ; DYNJ0038258B , Lot Number 21GBP285 ; DYNJ0038258B , Lot Number 21HBE871 ; DYNJ0038258B , Lot Number 21KBA841 ; DYNJ0038258B , Lot Number 21LBC977 ; DYNJ0038258B , Lot Number 22BBZ861 ; DYNJ0038258B , Lot Number 22BBZ863 ; DYNJ0038258B , Lot Number 22EBF434 ; DYNJ0038258B , Lot Number 22FBE051 ; DYNJ0038258B , Lot Number 22FBO305 ; DYNJ0038258B , Lot Number 22HBV626 ; DYNJ0038258B , Lot Number 22HBV627 ; DYNJ0038258B , Lot Number 22IBO524 ; DYNJ0038258B , Lot Number 19CKB171 ; DYNJ0038258B , Lot Number 19DKC919 ; DYNJ0038258B , Lot Number 19FKA727 ; DYNJ0038258B , Lot Number 19IKA276 ; DYNJ0038258B , Lot Number 19KKA943 ; DYNJ0038258B , Lot Number 19LKA532 ; DYNJ0038258B , Lot Number 20CKB393 ; DYNJ0038258B , Lot Number 20HKB130 ; DYNJ0038258B , Lot Number 20JKA474 ; DYNJ0038258B , Lot Number 20JKB817 ; DYNJ0038258B , Lot Number 20LKA793 ; DYNJ0038258B , Lot Number 21DKA240 ; DYNJ0042750, Lot Number 18LBN324 ; DYNJ0042750, Lot Number 19ABZ498 ; DYNJ0042750, Lot Number 19FBE166 ; DYNJ0042750, Lot Number 19GBC843 ; DYNJ0042750, Lot Number 19GBI214 ; DYNJ0042750, Lot Number 19TBB142 ; DYNJ0042750, Lot Number 19IBO724 ; DYNJ0042750, Lot Number 19JBA989 ; DYNJ0042750, Lot Number 19LBA797 ; DYNJ0046667A , Lot Number 20KMD297 ; DYNJ0046667A , Lot Number 21AMA700 ; DYNJ0046667A , Lot Number 21AMB340 ; DYNJ0046667A , Lot Number 21CMA516 ; DYNJ0046667A , Lot Number 21CME251 ; DYNJ0046667A , Lot Number 21EMB406 ; DYNJ0046667A , Lot Number 21FMC522 ; DYNJ0046667A , Lot Number 21GMC932 ; DYNJ0046667A , Lot Number 21HME119 ; DYNJ0046667A , Lot Number 21KMF215 ; DYNJ0046667A , Lot Number 21LMB634 ; DYNJ0046667A , Lot Number 22AMB834 ; DYNJ0046667A , Lot Number 22BMF198 ; DYNJ0046667A , Lot Number 22CMD979 ; DYNJ0046667A , Lot Number 22EMB660 ; DYNJ0046667A , Lot Number 22EMB661 ; DYNJ0046667A , Lot Number 22EMB662 ; DYNJ0046667A , Lot Number 22IMC899 ; DYNJ0046667A , Lot Number 22JMA806 ; DYNJ0046667A , Lot Number 23AMH225 ; DYNJ0046667A , Lot Number 23CMD768 ; DYNJ0046667A , Lot Number 23DMD610 ; DYNJ0046667A , Lot Number 23FMJ445 ; DYNJ0046667A , Lot Number 23HMG184 ; DYNJ0046667A , Lot Number 23JME529 ; DYNJ0046667A , Lot Number 18LKD146 ; DYNJ0046667A , Lot Number 19DKC398 ; DYNJ0046667A , Lot Number 19FKA728 ; DYNJ0046667A , Lot Number 19HKA236 ; DYNJ0046667A , Lot Number 19HKD274 ; DYNJ0046667A , Lot Number 19LKA508 ; DYNJ0046667A , Lot Number 20AKA856 ; DYNJ0046667A , Lot Number 20CKA873 ; DYNJ0046667A , Lot Number 20DKB067 ; DYNJ0046667A , Lot Number 20EKB692 ; DYNJ0046667A , Lot Number 20IKB197 ; DYNJ0048814I , Lot Number 20CBV335 ; DYNJ0048814I , Lot Number 20HBI988 ; DYNJ0048814I , Lot Number 20JBE866 ; DYNJ0048814I , Lot Number 20JBO448 ; DYNJ0048814I , Lot Number 20LBD173 ; DYNJ0048814I , Lot Number 21ABM406 ; DYNJ0048814I , Lot Number 21DBU587 ; DYNJ0048814I , Lot Number 21FMC720 ; DYNJ0048814I , Lot Number 21FMD918 ; DYNJ0048814I , Lot Number 21HMD222 ; DYNJ0048814I , Lot Number 21IMF561 ; DYNJ0048814I , Lot Number 21JMG514 ; DYNJ0048814I , Lot Number 21KMI266 ; DYNJ0048814I , Lot Number 22BME009 ; DYNJ0048814I , Lot Number 22DMD093 ; DYNJ0048814I , Lot Number 22FMF108 ; DYNJ0048814I , Lot Number 22FMG432 ; DYNJ0048814I , Lot Number 22HMD759 ; DYNJ0048814I , Lot Number 22HMD765 ; DYNJ0048814I , Lot Number 22KME286 ; DYNJ0048814I , Lot Number 22LMI976 ; DYNJ0048814I , Lot Number 23AMJ582 ; DYNJ0048814I , Lot Number 23DMB073 ; DYNJ0048814I , Lot Number 23DMB514 ; DYNJ0048814I , Lot Number 23EMF593 ; DYNJ0048814I , Lot Number 23FMC869 ; DYNJ0048814I , Lot Number 23GMC447 ; DYNJ0048814I , Lot Number 23HMF942 ; DYNJ0048814I , Lot Number 23IMD431 ; DYNJ0048814I , Lot Number 23JMF980 ; DYNJ0048814I , Lot Number 23JMK171 ; DYNJ0048814I , Lot Number 24AMB862 ; DYNJ0101440F , Lot Number 19BDC693 ; DYNJ0101440F , Lot Number 19DDB658 ; DYNJ0101440F , Lot Number 19EDB188 ; DYNJ0101440F , Lot Number 19FDC438 ; DYNJ0101440F , Lot Number 19GDC715 ; DYNJ0101440F , Lot Number 19IDB767 ; DYNJ0101440F , Lot Number 19LMB454 ; DYNJ0101440F , Lot Number 20AMA643 ; DYNJ0101440F , Lot Number 20BMB949 ; DYNJ0101440F , Lot Number 20CMB775 ; DYNJ0101440F , Lot Number 20GMC523 ; DYNJ0101440F , Lot Number 20IMB735 ; DYNJ0101440F , Lot Number 20JMA264 ; DYNJ0101440F , Lot Number 20KMB368 ; DYNJ0101440F , Lot Number 21BMD687 ; DYNJ0101440F , Lot Number 21DMC586 ; DYNJ0101440F , Lot Number 21FMA150 ; DYNJ0101440F , Lot Number 21GMG063 ; DYNJ0101440F , Lot Number 21IMA367 ; DYNJ0101440F , Lot Number 21IMH440 ; DYNJ0101440F , Lot Number 21KMD025 ; DYNJ0103039B , Lot Number 19ADA367 ; DYNJ0103039B , Lot Number 19CDD103 ; DYNJ0161028C , Lot Number 19ADC011 ; DYNJ0161028C , Lot Number 19CDA870 ; DYNJ0161028C , Lot Number 19EDA114 ; DYNJ0161028C , Lot Number 19FDB524 ; DYNJ0161028C , Lot Number 19IDA737 ; DYNJ0161028F , Lot Number 20EDA596 ; DYNJ0161028F , Lot Number 20JDB324 ; DYNJ0161028F , Lot Number 20JDC502 ; DYNJ0161028G , Lot Number 21DDB217 ; DYNJ0161028G , Lot Number 21GDA335 ; DYNJ0161028G , Lot Number 21HDC070 ; DYNJ0161028G , Lot Number 21IDA562 ; DYNJ0161028G , Lot Number 21KDC462 ; DYNJ0161028G , Lot Number 22ADB295 ; DYNJ0161028G , Lot Number 22DDA643 ; DYNJ0161028G , Lot Number 22DDB627 ; DYNJ0161028G , Lot Number 22EDB700 ; DYNJ0161028G , Lot Number 22GDA540 ; DYNJ0161028G , Lot Number 22HDA931 ; DYNJ0161028G , Lot Number 22KDB649 ; DYNJ0161028G , Lot Number 23BDA264 ; DYNJ0161028G , Lot Number 23DDB356 ; DYNJ0161028G , Lot Number 23EDA344 ; DYNJ0161028G , Lot Number 23FDC346 ; DYNJ0161028G , Lot Number 23IDC048 ; DYNJ0161028G , Lot Number 23JDB943 ; DYNJ0161619D , Lot Number 19AKB976 ; DYNJ0161619D , Lot Number 19BKD074 ; DYNJ0161619D , Lot Number 19DKB509 ; DYNJ0161619D , Lot Number 19FKB813 ; DYNJ0161619D , Lot Number 19HKA978 ; DYNJ0161619D , Lot Number 19JKA533 ; DYNJ0161619D , Lot Number 20AKB333 ; DYNJ0161619D , Lot Number 20CKA394 ; DYNJ0161811C , Lot Number 19CDC684 ; DYNJ0161811C , Lot Number 19EDA550 ; DYNJ0161811C , Lot Number 19EDC488 ; DYNJ0161811C , Lot Number 19FDB927 ; DYNJ0161811C , Lot Number 19HDD314 ; DYNJ0161811C , Lot Number 19JDC797 ; DYNJ01823F , Lot Number 20LMC392 ; DYNJ01823F , Lot Number 21DMB766 ; DYNJ01823F , Lot Number 21DME688 ; DYNJ01823F , Lot Number 21FME184 ; DYNJ01823F , Lot Number 19AKD454 ; DYNJ01823F , Lot Number 19EKA563 ; DYNJ01823F , Lot Number 19FKA054 ; DYNJ01823F , Lot Number 19GKA379 ; DYNJ01823F , Lot Number 19HKC508 ; DYNJ01823F , Lot Number 19JKB294 ; DYNJ01823F , Lot Number 19KKB652 ; DYNJ01823F , Lot Number 20AKB524 ; DYNJ01823F , Lot Number 20CKB333 ; DYNJ0193529A , Lot Number 19CKA325 ; DYNJ0193529A , Lot Number 19DKC680 ; DYNJ0193529A , Lot Number 19HKB577 ; DYNJ0193529A , Lot Number 19JKA066 ; DYNJ0193529A , Lot Number 19KKA094 ; DYNJ0193529A , Lot Number 19KKA289 ; DYNJ0193529A , Lot Number 19LKA299 ; DYNJ0193529A , Lot Number 19LKB456 ; DYNJ0193529A , Lot Number 20AKB916 ; DYNJ0193529A , Lot Number 20CKA033 ; DYNJ0193529A , Lot Number 20CKA077 ; DYNJ0287784R , Lot Number 20IMD811 ; DYNJ0287784R , Lot Number 20JME846 ; DYNJ0287784R , Lot Number 20KMC334 ; DYNJ0287784R , Lot Number 20KMF037 ; DYNJ0287784R , Lot Number 21CMA547 ; DYNJ0287784R , Lot Number 21CMA849 ; DYNJ0287784R , Lot Number 21DMA937 ; DYNJ0287784R , Lot Number 21EMD164 ; DYNJ0287784R , Lot Number 21FMF514 ; DYNJ0287784R , Lot Number 21GME374 ; DYNJ0287784R , Lot Number 21HMC513 ; DYNJ0287784R , Lot Number 21IME464 ; DYNJ0287784R , Lot Number 21LMG087 ; DYNJ0287784R , Lot Number 22AMA891 ; DYNJ0287784R , Lot Number 22AMD731 ; DYNJ0287784R , Lot Number 22EME354 ; DYNJ0287784R , Lot Number 22GMF493 ; DYNJ0287784R , Lot Number 22HMD708 ; DYNJ0287784R , Lot Number 22HMD709 ; DYNJ0287784R , Lot Number 22IMC118 ; DYNJ0287784R , Lot Number 23EMB596 ; DYNJ0287784R , Lot Number 23FMF477 ; DYNJ0287784R , Lot Number 23GMB518 ; DYNJ0287784R , Lot Number 23HMC923 ; DYNJ0287784R , Lot Number 23HMI493 ; DYNJ0287784R , Lot Number 23JMA809 ; DYNJ0287784R , Lot Number 23JMG394 ; DYNJ0287784R , Lot Number 23KMD177 ; DYNJ0287784R , Lot Number 23LMC232 ; DYNJ03387A , Lot Number 21GMD526 ; DYNJ03387A , Lot Number 21IME838 ; DYNJ03387A , Lot Number 21IMF945 ; DYNJ03387A , Lot Number 21KMF815 ; DYNJ03387A , Lot Number 22BME711 ; DYNJ03387A , Lot Number 22CMG065 ; DYNJ0362432L , Lot Number 19BBB944 ; DYNJ0362432L , Lot Number 19CBN902 ; DYNJ0362432L , Lot Number 19PBA437 ; DYNJ0362432L , Lot Number 19FBQ059 ; DYNJ0362432M , Lot Number 19HBE819 ; DYNJ0362432M , Lot Number 19IBL032 ; DYNJ0362432M , Lot Number 19KBK654 ; DYNJ0362432M , Lot Number 19KBX533 ; DYNJ0362432M , Lot Number 19LBQ355 ; DYNJ0362432M , Lot Number 20BBV266 ; DYNJ0362432M , Lot Number 20CBK549 ; DYNJ0362432M , Lot Number 20CBM858 ; DYNJ0362432M , Lot Number 20DBQ583 ; DYNJ0362432M , Lot Number 20EBV340 ; DYNJ0362432M , Lot Number 20GBI288 ; DYNJ0367126L , Lot Number 19PBB239 ; DYNJ0367126L , Lot Number 19EBC471 ; DYNJ0367126L , Lot Number 19FBS890 ; DYNJ0367126L , Lot Number 19GBO841 ; DYNJ0367126L , Lot Number 19HBH497 ; DYNJ0367126L , Lot Number 19AKC620 ; DYNJ0367126L , Lot Number 19BKA779 ; DYNJ0367126L , Lot Number 19DKB494 ; DYNJ0367126M , Lot Number 19IBQ205 ; DYNJ0367126M , Lot Number 19VBB532 ; DYNJ0367126M , Lot Number 19KBI378 ; DYNJ0367126N , Lot Number 19LBL376 ; DYNJ0367126N , Lot Number 20BBI172 ; DYNJ0367126N , Lot Number 20BBR282 ; DYNJ0367126N , Lot Number 20CBQ313 ; DYNJ0367126N , Lot Number 20EBE843 ; DYNJ0367126N , Lot Number 20EBP181 ; DYNJ0367126N , Lot Number 20IMC139 ; DYNJ0367126N , Lot Number 20LMC957 ; DYNJ0367126N , Lot Number 21AMA703 ; DYNJ0367126N , Lot Number 21BMA176 ; DYNJ0367126N , Lot Number 21BMD749 ; DYNJ0367126N , Lot Number 21EMB032 ; DYNJ0367126N , Lot Number 21FMC390 ; DYNJ0367126N , Lot Number 21GMF918 ; DYNJ0367126N , Lot Number 21HME287 ; DYNJ0367126N , Lot Number 21IMD629 ; DYNJ0367126N , Lot Number 21KMB761 ; DYNJ0367126N , Lot Number 22AMA629 ; DYNJ0367126N , Lot Number 22BMA660 ; DYNJ0367126N , Lot Number 22CMD023 ; DYNJ0367126N , Lot Number 22EME554 ; DYNJ0367126N , Lot Number 22GMG636 ; DYNJ0367126N , Lot Number 22HMD394 ; DYNJ0367126N , Lot Number 22IMD2

Distribution pattern

Worldwide distribution.

device · product 71 of 81

Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num

Z-3051-2024
Recall number
Z-3051-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

ACC010647A , Lot Number 23CDC070 ; ACC010647A , Lot Number 23DDA683 ; CDS760053K , Lot Number 22HBP517 ; CDS760053K , Lot Number 22HBS797 ; CDS760053K , Lot Number 22LBS190 ; CDS760053K , Lot Number 23ABC154 ; CDS760053K , Lot Number 23ABM789 ; CDS760053K , Lot Number 23EBB486 ; CDS760053K , Lot Number 23IBP664 ; CDS810010J , Lot Number 19BBU744 ; CDS810010J , Lot Number 19DBL815 ; CDS810010J , Lot Number 19FBH859 ; CDS810010J , Lot Number 19HBO222 ; CDS810010J , Lot Number 19IBG752 ; CDS810010J , Lot Number 20BBT732 ; CDS810010J , Lot Number 20CBY376 ; CDS810010J , Lot Number 20EBA044 ; CDS810010J , Lot Number 20FBF639 ; CDS810010J , Lot Number 21DBT774 ; CDS810010K , Lot Number 21IBI534 ; CDS810010K , Lot Number 21JBM642 ; CDS810010K , Lot Number 21KBT225 ; CDS810010K , Lot Number 21KBY732 ; CDS810010K , Lot Number 21LBJ661 ; CDS810010K , Lot Number 22BBT607 ; CDS810010K , Lot Number 22FBG549 ; CDS810010K , Lot Number 22FBG555 ; CDS810010K , Lot Number 22HBF177 ; CDS810010K , Lot Number 23DBF386 ; 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DYNJ01263J , Lot Number 22HBQ659 ; DYNJ01263J , Lot Number 22JBH604 ; DYNJ01263J , Lot Number 22KBV909 ; DYNJ01263J , Lot Number 23BBK554 ; DYNJ01263J , Lot Number 23BBK555 ; DYNJ01263J , Lot Number 23DBP008 ; DYNJ01263J , Lot Number 23FBT681 ; DYNJ01263J , Lot Number 23HBO853 ; DYNJ01263J , Lot Number 23IBU235 ; DYNJ01263J , Lot Number 23KBN952 ; DYNJ0129784R , Lot Number 21EMC227 ; DYNJ0129784R , Lot Number 21GMA818 ; DYNJ0129784R , Lot Number 21HMA653 ; DYNJ0129784R , Lot Number 21JMH377 ; DYNJ0129784R , Lot Number 22CMH640 ; DYNJ0129784R , Lot Number 22DMG234 ; DYNJ0129784R , Lot Number 22EMG454 ; DYNJ0129784R , Lot Number 22FME857 ; DYNJ0129784R , Lot Number 22HMH532 ; DYNJ0129784R , Lot Number 23AMF340 ; DYNJ0129784R , Lot Number 23DMA089 ; DYNJ0129784R , Lot Number 23FMB605 ; DYNJ0129784R , Lot Number 23FME876 ; DYNJ0129784R , Lot Number 23GME766 ; DYNJ0129784RH, Lot Number 21EMC227 ; DYNJ0129784RH, Lot Number 21GMA818 ; DYNJ0129784RH, Lot Number 21HMA653 ; DYNJ0129784RH, Lot Number 21JMH377 ; DYNJ0129784RH, Lot Number 22CMH640 ; DYNJ0129784RH, Lot Number 22DMG234 ; DYNJ0129784RH, Lot Number 22EMG454 ; DYNJ0129784RH, Lot Number 22FME857 ; DYNJ0129784RH, Lot Number 22HMH532 ; DYNJ0129784RH, Lot Number 23AMF340 ; DYNJ0129784RH, Lot Number 23DMA089 ; DYNJ0129784RH, Lot Number 23FMB605 ; DYNJ0129784RH, Lot Number 23FME876 ; DYNJ0129784RH, Lot Number 23GME766 ; DYNJ0132717F , Lot Number 19AKD425 ; DYNJ0132717F , Lot Number 19CKC428 ; DYNJ0132717F , Lot Number 19EKD179 ; DYNJ0132717F , Lot Number 19GKC542 ; DYNJ0132717F , Lot Number 19HKC402 ; DYNJ0132717F , Lot Number 19KKA631 ; DYNJ0132717F , Lot Number 19LKA367 ; DYNJ0132717F , Lot Number 20BKA491 ; DYNJ0132717F , Lot Number 20CKB728 ; DYNJ0132717G , Lot Number 21AMB537 ; DYNJ0132717G , Lot Number 21BMD547 ; DYNJ0132717G , Lot Number 21CMC225 ; DYNJ0132717G , Lot Number 21EMB752 ; DYNJ0132717G , Lot Number 21GMD123 ; DYNJ0132717G , Lot Number 21HMA656 ; DYNJ0132717G , Lot Number 21IMG058 ; DYNJ0132717G , Lot Number 21KMG279 ; DYNJ0132717G , Lot Number 22AMD355 ; DYNJ0132717G , Lot Number 22EME992 ; DYNJ0132717G , Lot Number 22JMA363 ; DYNJ0132717G , Lot Number 23AMD224 ; DYNJ0132717G , Lot Number 23DMH662 ; DYNJ0132717G , Lot Number 23FMH282 ; DYNJ0132717G , Lot Number 23HMB144 ; DYNJ0132717G , Lot Number 23LMC007 ; DYNJ0132717G , Lot Number 20IKB410 ; DYNJ0141239Q , Lot Number 23IMF418 ; DYNJ0141239Q , Lot Number 23JMH202 ; DYNJ0141239Q , Lot Number 23LMC175 ; DYNJ0151148B , Lot Number 19BDA511 ; DYNJ0151148B , Lot Number 19DDA264 ; DYNJ0151148B , Lot Number 19EDD280 ; DYNJ0151148B , Lot Number 19GDC917 ; DYNJ0151148B , Lot Number 19IDC424 ; DYNJ0151148B , Lot Number 19KDA420 ; DYNJ0151148B , Lot Number 20ADA641 ; DYNJ0151148B , Lot Number 20BDA341 ; DYNJ0151148B , Lot Number 20DDB800 ; DYNJ0151148B , Lot Number 20GDC135 ; DYNJ0151148B , Lot Number 20HDC655 ; DYNJ0151148B , Lot Number 20IDC656 ; DYNJ0151148B , Lot Number 20JDA843 ; DYNJ0151148B , Lot Number 20KDB750 ; DYNJ0151148B , Lot Number 21BDA830 ; DYNJ0151148B , Lot Number 21FDA289 ; DYNJ0151148B , Lot Number 21HDB091 ; DYNJ0151148B , Lot Number 21IDB080 ; DYNJ0151148B , Lot Number 21KDA317 ; DYNJ0151148B , Lot Number 22ADB318 ; DYNJ0151148B , Lot Number 22CDB881 ; DYNJ0151148B , Lot Number 22DDB178 ; DYNJ0151148B , Lot Number 22FDB672 ; DYNJ0151148B , Lot Number 22GDC187 ; DYNJ0151148B , Lot Number 22IDB850 ; DYNJ0151148B , Lot Number 22LDB559 ; DYNJ0151148B , Lot Number 23BDB899 ; DYNJ0151148B , Lot Number 23CDC599 ; DYNJ0151148B , Lot Number 23FDA724 ; DYNJ0151148B , Lot Number 23GDB689 ; DYNJ0151148B , Lot Number 23HDA511 ; DYNJ0151148B , Lot Number 23IDB755 ; DYNJ0151148B , Lot Number 23KDB981 ; DYNJ0151148B , Lot Number 24BDA143 ; DYNJ0159122I , Lot Number 19AKB226 ; DYNJ0159122J , Lot Number 19BKB430 ; DYNJ0159122J , Lot Number 19CKD942 ; DYNJ0159122J , Lot Number 19DKC541 ; DYNJ0159122J , Lot Number 19GKA736 ; DYNJ0159122K , Lot Number 21FMA329 ; DYNJ0159122K , Lot Number 21GMA775 ; DYNJ0159122K , Lot Number 21GMG244 ; DYNJ0159122K , Lot Number 21HME745 ; DYNJ0159122K , Lot Number 21KMH418 ; DYNJ0159122K , Lot Number 21LMF708 ; DYNJ0159122K , Lot Number 22AMD352 ; DYNJ0159122K , Lot Number 22AMD473 ; DYNJ0159122K , Lot Number 22FMI176 ; DYNJ0159122K , Lot Number 22IMD119 ; DYNJ0159122K , Lot Number 19IKB052 ; DYNJ0159122K , Lot Number 19KKB377 ; DYNJ0159122K , Lot Number 20BKB188 ; DYNJ0159122K , Lot Number 20FKB223 ; DYNJ0159122K , Lot Number 20GKA503 ; DYNJ0159122K , Lot Number 20IKB039 ; DYNJ0159122K , Lot Number 20KKA404 ; DYNJ0159122K , Lot Number 21BKA079 ; DYNJ0159122K , Lot Number 21DKA305 ; DYNJ0159122L , Lot Number 22KME945 ; DYNJ0159122L , Lot Number 23AMB043 ; DYNJ0159122M , Lot Number 23CMC433 ; DYNJ0159122M , Lot Number 23DMB080 ; DYNJ0159122M , Lot Number 23DME120 ; DYNJ0159122M , Lot Number 23FMG588 ; DYNJ0159122M , Lot Number 23FMH390 ; DYNJ0159122M , Lot Number 23HMG308 ; DYNJ0159122M , Lot Number 23IMB201 ; DYNJ0159122M , Lot Number 23KMH318 ; DYNJ0159122M , Lot Number 24AMC084 ; DYNJ0159809B , Lot Number 22GDA626 ; DYNJ0168810Q , Lot Number 20LMA963 ; DYNJ0168810Q , Lot Number 19AKC826 ; DYNJ0168810Q , Lot Number 19CKC614 ; DYNJ0190619F , Lot Number 19BKB500 ; DYNJ0190619F , Lot Number 19EKC082 ; DYNJ0190619F , Lot Number 19HKA182 ; DYNJ0190619F , Lot Number 19HKC296 ; DYNJ0190619F , Lot Number 19HKC788 ; DYNJ0190619F , Lot Number 20DKA732 ; DYNJ0190619F , Lot Number 20FKB285 ; DYNJ0190619F , Lot Number 20JKA020 ; DYNJ0190619G , Lot Number 20KMC490 ; DYNJ0190619G , Lot Number 20LMC608 ; DYNJ0190619G , Lot Number 21IMH127 ; DYNJ0190619G , Lot Number 22AMB048 ; DYNJ0190619G , Lot Number 23AMJ263 ; DYNJ0198189D , Lot Number 19BKC561 ; DYNJ0200004B , Lot Number 19EBN539 ; DYNJ0200004B , Lot Number 19EBX494 ; DYNJ0200004B , Lot Number 19HBO160 ; DYNJ0200004B , Lot Number 19TBE985 ; DYNJ0200004B , Lot Number 19IBY803 ; DYNJ0200004B , Lot Number 19KBL633 ; DYNJ0200004B , Lot Number 20BBW037 ; DYNJ0200004B , Lot Number 20DBD156 ; DYNJ0200004B , Lot Number 20FBS414 ; DYNJ0200004B , Lot Number 20FBU454 ; DYNJ0200004B , Lot Number 20IBI821 ; DYNJ0200004B , Lot Number 20IBL143 ; DYNJ0200004B , Lot Number 20JBN183 ; DYNJ0200004B , Lot Number 20KBZ513 ; DYNJ0200004B , Lot Number 20LBU313 ; DYNJ0200004B , Lot Number 21DBJ821 ; DYNJ0200004B , Lot Number 21HMG460 ; DYNJ0200004B , Lot Number 21IMB734 ; DYNJ0200004B , Lot Number 21JMA317 ; DYNJ0200004B , Lot Number 21KMB559 ; DYNJ0200004B , Lot Number 21KME916 ; DYNJ0200004B , Lot Number 22DMI415 ; DYNJ0200004B , Lot Number 22HME610 ; DYNJ0200004B , Lot Number 22IMD552 ; DYNJ0200004B , Lot Number 22JMH859 ; DYNJ0200004B , Lot Number 22LMH732 ; DYNJ0200004B , Lot Number 23BMA084 ; DYNJ0200004B , Lot Number 23CMA756 ; DYNJ0200004B , Lot Number 23DMB082 ; DYNJ0200004B , Lot Number 23EMK172 ; DYNJ0200004B , Lot Number 23GME617 ; DYNJ0200004B , Lot Number 23GMI902 ; DYNJ0200004B , Lot Number 23IME604 ; DYNJ0200004B , Lot Number 23KMA198 ; DYNJ0200004B , Lot Number 23KMJ007 ; DYNJ0200004B , Lot Number 23LME804 ; DYNJ0200004B , Lot Number 19AKB801 ; DYNJ0200004B , Lot Number 19BKC639 ; DYNJ0200004B , Lot Number 19DKA919 ; DYNJ0259872L , Lot Number 19LMA530 ; DYNJ0259872L , Lot Number 20BMA740 ; DYNJ0259872L , Lot Number 20EMB246 ; DYNJ0259872L , Lot Number 21FMF695 ; DYNJ0259872L , Lot Number 21IMA827 ; DYNJ0259872L , Lot Number 22AMC338 ; DYNJ0259872L , Lot Number 22HME763 ; DYNJ0259872L , Lot Number 22HME788 ; DYNJ0259872L , Lot Number 19HKA176 ; DYNJ02602D , Lot Number 19FBT873 ; DYNJ02602D , Lot Number 19ADD166 ; DYNJ02602D , Lot Number 19DDC154 ; DYNJ02602D , Lot Number 19GDA990 ; DYNJ02602D , Lot Number 19IDA302 ; DYNJ02602D , Lot Number 19KDA819 ; DYNJ02602D , Lot Number 20ADC403 ; DYNJ02602D , Lot Number 20GDA386 ; DYNJ02602D , Lot Number 20HDC553 ; DYNJ02602D , Lot Number 20KDA012 ; DYNJ02602D , Lot Number 21ADA699 ; DYNJ02602F , Lot Number 21DDB755 ; DYNJ02602F , Lot Number 21GDA028 ; DYNJ02602G , Lot Number 21HDB505 ; DYNJ02602G , Lot Number 21JDA497 ; DYNJ02602G , Lot Number 21KDB695 ; DYNJ02602G , Lot Number 22DDB775 ; DYNJ02602G , Lot Number 22FDA206 ; DYNJ02602G , Lot Number 22GDA402 ; DYNJ02602G , Lot Number 22HDA755 ; DYNJ02602G , Lot Number 22IDC106 ; DYNJ02602G , Lot Number 22LDB934 ; DYNJ02602G , Lot Number 24ADB473 ; DYNJ02602G , Lot Number 24CDA263 ; DYNJ0261302S , Lot Number 19AKB977 ; DYNJ0261302T , Lot Number 19IMA826 ; DYNJ0261302T , Lot Number 20AMA283 ; DYNJ0261302T , Lot Number 20AMA994 ; DYNJ0261302T , Lot Number 20FMA421 ; DYNJ0261302T , Lot Number 20GMC134 ; DYNJ0261302T , Lot Number 20GMD233 ; DYNJ0261302T , Lot Number 20HMD645 ; DYNJ0261302T , Lot Number 20IMD460 ; DYNJ0261302T , Lot Number 20JMB141 ; DYNJ0261302T , Lot Number 20KMA533 ; DYNJ0261302T , Lot Number 20LMA828 ; DYNJ0261302T , Lot Number 21EMC915 ; DYNJ0261302T , Lot Number 21GMB540 ; DYNJ0261302T , Lot Number 21HMA966 ; DYNJ0261302T , Lot Number 21LMA726 ; DYNJ0261302T , Lot Number 22BMD710 ; DYNJ0261302T , Lot Number 22DMA393 ; DYNJ0261302T , Lot Number 22FME154 ; DYNJ0261302T , Lot Number 22HMA672 ; DYNJ0261302T , Lot Number 23AMI832 ; DYNJ0261302T , Lot Number 23CMC778 ; DYNJ0261302T , Lot Number 23DME462 ; DYNJ0261302T , Lot Number 23FMC970 ; DYNJ0261302T , Lot Number 23GMA567 ; DYNJ0261302T , Lot Number 23GMG148 ; DYNJ0261302T , Lot Number 19CKD830 ; DYNJ0261302T , Lot Number 19EKB885 ; DYNJ0261302T , Lot Number 19EKD590 ; DYNJ0261302T , Lot Number 19HKC932 ; DYNJ0261302U , Lot Number 23KMH937 ; DYNJ0261302U , Lot Number 24AME529 ; DYNJ0264973AK, Lot Number 19AKC942 ; DYNJ0264973AK, Lot Number 19BKD839 ; DYNJ0264973AL, Lot Number 19HMA336 ; DYNJ0264973AL, Lot Number 19JMA158 ; DYNJ0264973AL, Lot Number 19LMC513 ; DYNJ0264973AL, Lot Number 20BMB417 ; DYNJ0264973AL, Lot Number 20GMC925 ; DYNJ0264973AL, Lot Number 20HMD613 ; DYNJ0264973AL, Lot Number 20LMD020 ; DYNJ0264973AL, Lot Number 21BMA307 ; DYNJ0264973AL, Lot Number 21CMC662 ; DYNJ0264973AL, Lot Number 21FMA751 ; DYNJ0264973AL, Lot Number 19DKA841 ; DYNJ0264973AL, Lot Number 19EKB824 ; DYNJ0264973AL, Lot Number 19FKB438 ; DYNJ0264973AM, Lot Number 21GME384 ; DYNJ0264973AM, Lot Number 21IMC453 ; DYNJ0264973AM, Lot Number 21KMB235 ; DYNJ0264973AM, Lot Number 21KMF571 ; DYNJ0264973AM, Lot Number 22CMB137 ; DYNJ0264973AN, Lot Number 22CMH757 ; DYNJ0264973AN, Lot Number 22DMG902 ; DYNJ0264973AN, Lot Number 22FMB109 ; DYNJ0264973AN, Lot Number 22GME283 ; DYNJ0264973AN, Lot Number 22HMH087 ; DYNJ0264973AN, Lot Number 22IMF597 ; DYNJ0264973AN, Lot Number 22JMC535 ; DYNJ0264973AN, Lot Number 22KMA337 ; DYNJ0264973AN, Lot Number 22LMA916 ; DYNJ0264973AN, Lot Number 23AMC177 ; DYNJ0264973AN, Lot Number 23BMH985 ; DYNJ0264973AN, Lot Number 23CME770 ; DYNJ0264973AN, Lot Number 23DME279 ; DYNJ0264973AN, Lot Number 23EMA986 ; DYNJ0264973AN, Lot Number 23FMC126 ; DYNJ0264973AN, Lot Number 23FMI581 ; DYNJ0264973AN, Lot Number 23HMD719 ; DYNJ0264973AN, Lot Number 23IMI062 ; DYNJ0264973AN, Lot Number 23KMI350 ; DYNJ0264973AN, Lot Number 24AMI588 ; DYNJ0275124L , Lot Number 19AKC126 ; DYNJ0275124L , Lot Number 19BKD558 ; DYNJ0275124L , Lot Number 19CKD029 ; DYNJ0275124L , Lot Number 19DKB536 ; DYNJ0275124L , Lot Number 19EKC498 ; DYNJ0275124L , Lot Number 19GKB277 ; DYNJ0275124L , Lot Number 19IKA328 ; DYNJ0275124L , Lot Number 19IKC250 ; DYNJ0275124L , Lot Number 19KKB069 ; DYNJ0275124L , Lot Number 19LKB565 ; DYNJ0290924N , Lot Number 21IBV454 ; DYNJ0290924N , Lot Number 21KBJ472 ; DYNJ0290924N , Lot Number 22NBE802 ; DYNJ0290924N , Lot Number 19HBR213 ; DYNJ0290924N , Lot Number 19IBZ882 ; DYNJ0290924N , Lot Number 19KBJ762 ; DYNJ0290924N , Lot Number 19LBV945 ; DYNJ0290924N , Lot Number 20GBH377 ; DYNJ0290924N , Lot Number 20HBS832 ; DYNJ0290924N , Lot Number 21CBJ791 ; DYNJ0290924N , Lot Number 23BMH691 ; DYNJ0290924N , Lot Number 23DMI749 ; DYNJ0317858M , Lot Number 22IMC900 ; DYNJ0317858M , Lot Number 22IMD667 ; DYNJ0317858M , Lot Number 22JMF894 ; DYNJ0317858M , Lot Number 22KMH111 ; DYNJ0317858M , Lot Number 23GMB519 ; DYNJ0336700D , Lot Number 21EBP815 ; DYNJ0336700D , Lot Number 20GKA064 ; DYNJ0336700D , Lot Number 20HKB183 ; DYNJ0336700D , Lot Number 20IKB242 ; DYNJ0336700F , Lot Number 21IBV397 ; DYNJ0336700F , Lot Number 21KBG921 ; DYNJ0336700F , Lot Number 22GMG060 ; DYNJ0336700F , Lot Number 22JMC537 ; DYNJ0336700F , Lot Number 23AMF230 ; DYNJ0336700F , Lot Number 23EMB598 ; DYNJ0336700F , Lot Number 23FMA974 ; DYNJ033670

Distribution pattern

Worldwide distribution.

device · product 72 of 81

Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe

Z-3052-2024
Recall number
Z-3052-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

00-399024X , Lot Number 19CBL066 ; 00-399024X , Lot Number 19FBI397 ; 00-399024X , Lot Number 19RBC685 ; 00-399024X , Lot Number 19HBD864 ; 00-399024X , Lot Number 19JBV149 ; 00-399024X , Lot Number 20ABH766 ; 00-399024X , Lot Number 20ABO115 ; 00-399024X , Lot Number 20CBC862 ; AM110A , Lot Number 21GBK629 ; AM110A , Lot Number 19HBC424 ; AM110A , Lot Number 19JBR312 ; AM110A , Lot Number 19KBL415 ; AM110A , Lot Number 20ABK847 ; AM110A , Lot Number 20GBU689 ; AM110A , Lot Number 20HBK170 ; AM110A , Lot Number 20LBN052 ; AM110A , Lot Number 20LBW697 ; AM110A , Lot Number 21CBB960 ; AM110A , Lot Number 21FBC989 ; BM200A , Lot Number 19EBU942 ; BM230A , Lot Number 22CBC356 ; BM230A , Lot Number 19DBJ049 ; BM230A , Lot Number 19UBA244 ; BM230A , Lot Number 19JBQ486 ; BM230A , Lot Number 20DBF398 ; BM230A , Lot Number 20IBB552 ; BM230A , Lot Number 20JBR898 ; BM240A , Lot Number 21IBR974 ; BM240A , Lot Number 22BBC921 ; BM240A , Lot Number 19CBF549 ; BM240A , Lot Number 19EBV048 ; BM240A , Lot Number 20DBS054 ; BM240A , Lot Number 20GBU725 ; BM240A , Lot Number 20KBS381 ; BM240A , Lot Number 20KBX781 ; BM240A , Lot Number 21BBJ873 ; BM240A , Lot Number 21DBI364 ; BM250A , Lot Number 21LBI573 ; BM250A , Lot Number 22EBQ666 ; BM250A , Lot Number 19HBG435 ; BM250A , Lot Number 19JBD740 ; BM250A , Lot Number 20ABK834 ; BM250A , Lot Number 20DBR991 ; BM250A , Lot Number 20EBT982 ; BM250A , Lot Number 20GBC494 ; BM250A , Lot Number 20GBN979 ; BM250A , Lot Number 23LBT030 ; BM250A , Lot Number 20KBA693 ; BM250A , Lot Number 21ABA267 ; BM250A , Lot Number 21ABF688 ; BM250A , Lot Number 21BBM607 ; CDS780025AA, Lot Number 21ABG344 ; CDS780025AA, Lot Number 21BBI957 ; CDS780025AA, Lot Number 21CBD927 ; CDS780025AB, Lot Number 21HBL624 ; CDS780025AB, Lot Number 21IBL720 ; CDS780025AB, Lot Number 21LBU758 ; CDS780025AB, Lot Number 22CBP174 ; CDS780025AB, Lot Number 22EBN090 ; CDS780025AB, Lot Number 22GBH493 ; CDS780025AB, Lot Number 22HBB637 ; CDS780025AC, Lot Number 22LBF788 ; CDS780025AC, Lot Number 23CBX130 ; CDS780025AC, Lot Number 23EBJ659 ; CDS780025AC, Lot Number 23FBH173 ; CDS780025AC, Lot Number 23IBI612 ; CDS780025AC, Lot Number 23KBC083 ; CDS780025AC, Lot Number 24BBB443 ; CDS780025X , Lot Number 19ABP155 ; CDS780025X , Lot Number 19ABQ093 ; CDS780025X , Lot Number 19ABY942 ; CDS780025X , Lot Number 19CBE111 ; CDS780025X , Lot Number 19FBV023 ; CDS780025Y , Lot Number 19EBO302 ; CDS780025Y , Lot Number 19EBO396 ; CDS780025Y , Lot Number 19KBQ760 ; CDS780025Y , Lot Number 19KBU716 ; CDS780025Y , Lot Number 19LBF130 ; CDS780025Y , Lot Number 20DBO129 ; CDS780025Y , Lot Number 20GBQ281 ; CDS780025Y , Lot Number 20GBS047 ; CDS780025Y , Lot Number 20JBY248 ; CDS780045M , Lot Number 19BBH900 ; CDS780045M , Lot Number 19CBC615 ; CDS780045M , Lot Number 19DBC309 ; CDS780045M , Lot Number 19EBU628 ; CDS780045M , Lot Number 19EBU835 ; CDS780045M , Lot Number 19GBR400 ; CDS780045M , Lot Number 19SBC898 ; CDS780045M , Lot Number 19VBE307 ; CDS780045M , Lot Number 19KBN002 ; CDS780045M , Lot Number 19KBT829 ; CDS780045M , Lot Number 20BBJ961 ; CDS780045M , Lot Number 20CBP221 ; CDS780045N , Lot Number 21FBL891 ; CDS780045N , Lot Number 21FBS507 ; CDS780045N , Lot Number 21JBU289 ; CDS780045N , Lot Number 21LBP574 ; CDS780045N , Lot Number 22DBA187 ; CDS780045N , Lot Number 22DBB694 ; CDS780045N , Lot Number 22FBM376 ; CDS780045N , Lot Number 22GBG444 ; CDS780045N , Lot Number 22GBG445 ; CDS780045N , Lot Number 22JBI816 ; CDS780045N , Lot Number 22JBI817 ; CDS780045N , Lot Number 22LBP661 ; CDS780045N , Lot Number 23CBR748 ; CDS780045N , Lot Number 20GBC500 ; CDS780045N , Lot Number 20GBD251 ; CDS780045N , Lot Number 20GBL415 ; CDS780045N , Lot Number 20GBQ383 ; CDS780045N , Lot Number 20IBN736 ; CDS780045N , Lot Number 20JBX378 ; CDS780045N , Lot Number 20LBC750 ; CDS780045N , Lot Number 21BBF167 ; CDS780045O , Lot Number 23DBP671 ; CDS780045O , Lot Number 23EBT969 ; CDS780045O , Lot Number 23FBU385 ; CDS780046O , Lot Number 21GBR876 ; CDS780046O , Lot Number 22ABW880 ; CDS780046O , Lot Number 22BBE256 ; CDS780046O , Lot Number 19PBB747 ; CDS780046O , Lot Number 19FBL893 ; CDS780046O , Lot Number 22GBY297 ; CDS780046O , Lot Number 22JBW313 ; CDS780046O , Lot Number 22KBH412 ; CDS780046O , Lot Number 23ABK644 ; CDS780046O , Lot Number 23BBA110 ; CDS780046O , Lot Number 20DBU225 ; CDS780046O , Lot Number 20EBD305 ; CDS780046O , Lot Number 20EBU069 ; CDS780046O , Lot Number 20GBK459 ; CDS780046O , Lot Number 20GBQ343 ; CDS780046O , Lot Number 20HBC287 ; CDS780046O , Lot Number 20JBE768 ; CDS780046O , Lot Number 21BBE934 ; CDS780046O , Lot Number 21BBF841 ; CDS780046O , Lot Number 21CBO851 ; CDS780046O , Lot Number 21DBA629 ; CDS780046O , Lot Number 21EBK749 ; CDS780089V , Lot Number 19BLA484 ; CDS780089V , Lot Number 19CLA199 ; CDS780089V , Lot Number 19DLA506 ; CDS780089V , Lot Number 19ELA586 ; CDS780089V , Lot Number 19FLA443 ; CDS780089V , Lot Number 19ILA292 ; CDS780089V , Lot Number 19KLA012 ; CDS780089V , Lot Number 20ALA302 ; CDS780089V , Lot Number 20BLA154 ; CDS780089V , Lot Number 20CLA346 ; CDS780089V , Lot Number 20CLA377 ; CDS780089V , Lot Number 20ELA650 ; CDS780089V , Lot Number 20FLA192 ; CDS780089V , Lot Number 20GLA323 ; CDS780089V , Lot Number 20HLA062 ; CDS780089V , Lot Number 20KLA347 ; CDS780089V , Lot Number 20LLA017 ; CDS780089V , Lot Number 21ALA247 ; CDS780089W , Lot Number 21ELA499 ; CDS780089W , Lot Number 21ELA714 ; CDS780089W , Lot Number 21ILA014 ; CDS780089W , Lot Number 21ILA871 ; CDS780089X , Lot Number 21LLA724 ; CDS780089X , Lot Number 21LLA794 ; CDS780089X , Lot Number 21LLA962 ; CDS780089X , Lot Number 22BLB011 ; CDS780089X , Lot Number 22DLB117 ; CDS780089X , Lot Number 22FLA045 ; CDS780089X , Lot Number 22GLA532 ; CDS780089X , Lot Number 22ILA257 ; CDS780089X , Lot Number 22KLB074 ; CDS780089X , Lot Number 23BLA523 ; CDS780089X , Lot Number 23CLB179 ; CDS780089X , Lot Number 23ELA364 ; CDS780089X , Lot Number 23ILA376 ; CDS780089X , Lot Number 23JLA126 ; CDS780089X , Lot Number 23JLA704 ; CDS780089X , Lot Number 23JLB027 ; CDS780089X , Lot Number 24BLA505 ; CDS780102K , Lot Number 21HBJ414 ; CDS780102K , Lot Number 21IBA053 ; CDS780102K , Lot Number 21JBD207 ; CDS780102K , Lot Number 21KBC783 ; CDS780102K , Lot Number 21KBV808 ; CDS780102K , Lot Number 21KBV809 ; CDS780102K , Lot Number 19DBN638 ; CDS780102K , Lot Number 19EBN450 ; CDS780102K , Lot Number 22GBE917 ; CDS780102K , Lot Number 19FBN031 ; CDS780102K , Lot Number 22HBD316 ; CDS780102K , Lot Number 22IBE293 ; CDS780102K , Lot Number 22IBT392 ; CDS780102K , Lot Number 19JBE273 ; CDS780102K , Lot Number 19JBI710 ; CDS780102K , Lot Number 19KBR616 ; CDS780102K , Lot Number 20BBQ409 ; CDS780102K , Lot Number 20CBP611 ; CDS780102K , Lot Number 20EBG877 ; CDS780102K , Lot Number 20EBS145 ; CDS780102K , Lot Number 20FBB178 ; CDS780102K , Lot Number 20FBR886 ; CDS780102K , Lot Number 20JBH667 ; CDS780102K , Lot Number 21BBJ070 ; CDS780102K , Lot Number 21DBH746 ; CDS780102L , Lot Number 23ABC312 ; CDS780102L , Lot Number 23DBT155 ; CDS780102L , Lot Number 23GBS654 ; CDS780104L , Lot Number 22BBD890 ; CDS780104L , Lot Number 22OBL743 ; CDS780104L , Lot Number 22IBR905 ; CDS780104L , Lot Number 22KBB817 ; CDS780104L , Lot Number 23ABM657 ; CDS780104L , Lot Number 23CBH325 ; CDS780104L , Lot Number 23DBT179 ; CDS780104L , Lot Number 23IBS971 ; CDS780104L , Lot Number 23IBT047 ; CDS780104L , Lot Number 23LBE523 ; CDS780104L , Lot Number 23LBE671 ; CDS780105K , Lot Number 21FBN763 ; CDS780105K , Lot Number 21IBS477 ; CDS780105K , Lot Number 21JBH424 ; CDS780105K , Lot Number 19CBB271 ; CDS780105K , Lot Number 19DBI491 ; CDS780105K , Lot Number 19EBB829 ; CDS780105K , Lot Number 19EBN421 ; CDS780105K , Lot Number 19FBD123 ; CDS780105K , Lot Number 19GBC919 ; CDS780105K , Lot Number 19IBH668 ; CDS780105K , Lot Number 19JBR671 ; CDS780105K , Lot Number 20ABE319 ; CDS780105K , Lot Number 20CBC162 ; CDS780105K , Lot Number 20FBF445 ; CDS780105K , Lot Number 20GBD844 ; CDS780105K , Lot Number 20IBD944 ; CDS780105K , Lot Number 20LBD264 ; CDS780105K , Lot Number 21ABW337 ; CDS780105K , Lot Number 21DBF100 ; CDS780105L , Lot Number 22CBG769 ; CDS780105L , Lot Number 22DBI992 ; CDS780105L , Lot Number 22EBE861 ; CDS780105L , Lot Number 22FBW180 ; CDS780105L , Lot Number 22GBA843 ; CDS780105L , Lot Number 22HBI798 ; CDS780105L , Lot Number 22IBA597 ; CDS780105L , Lot Number 23ABD934 ; CDS780105L , Lot Number 23ABE600 ; CDS780105L , Lot Number 23DBD675 ; CDS780105L , Lot Number 23FBA008 ; CDS780105L , Lot Number 23FBA141 ; CDS780105L , Lot Number 23HBQ153 ; CDS780105L , Lot Number 23JBL140 ; CDS780105L , Lot Number 23LBQ382 ; CDS780109P , Lot Number 23KBM336 ; CDS780109P , Lot Number 24ABL060 ; CDS780111M , Lot Number 19BBO520 ; CDS780111M , Lot Number 19DBD837 ; CDS780111M , Lot Number 19GBS443 ; CDS780111M , Lot Number 19IBX646 ; CDS780111M , Lot Number 19JBY659 ; CDS780111M , Lot Number 20DBS612 ; CDS780111N , Lot Number 21HBS235 ; CDS780111N , Lot Number 21HBS239 ; CDS780111N , Lot Number 20HBP056 ; CDS780111N , Lot Number 20IBC457 ; CDS780111N , Lot Number 20IBN729 ; CDS780111N , Lot Number 20LBP958 ; CDS780111N , Lot Number 20XBI191 ; CDS780111N , Lot Number 21DBP206 ; CDS780111O , Lot Number 22BBS177 ; CDS780111O , Lot Number 22OBD871 ; CDS780111O , Lot Number 22DBP856 ; CDS780111O , Lot Number 22FBY057 ; CDS780111O , Lot Number 22KBD815 ; CDS780111O , Lot Number 23ABR378 ; CDS780111O , Lot Number 23BBT628 ; CDS780111O , Lot Number 23IBK502 ; CDS780111O , Lot Number 23JBP367 ; CDS780111P , Lot Number 24ABL026 ; CDS780111P , Lot Number 24BBK181 ; CDS780119U , Lot Number 21HBB379 ; CDS780119U , Lot Number 21IBV579 ; CDS780119U , Lot Number 21KBV760 ; CDS780119U , Lot Number 21KBV761 ; CDS780119U , Lot Number 22CBL018 ; CDS780119U , Lot Number 20HBC289 ; CDS780119U , Lot Number 20JBX601 ; CDS780119U , Lot Number 21ABJ206 ; CDS780119U , Lot Number 21CBC828 ; CDS780119V , Lot Number 22DBN874 ; CDS780119V , Lot Number 22FBU189 ; CDS780119V , Lot Number 22HBO015 ; CDS780119V , Lot Number 22KBN442 ; CDS780119V , Lot Number 23ABF941 ; CDS780119V , Lot Number 23BBQ326 ; CDS780119V , Lot Number 23DBE182 ; CDS780119V , Lot Number 23GBQ904 ; CDS780119V , Lot Number 23JBS979 ; CDS780119V , Lot Number 23LBD741 ; CDS780119V , Lot Number 24ABF767 ; CDS780119V , Lot Number 24BBK027 ; CDS780119VH, Lot Number 22DBN874 ; CDS780119VH, Lot Number 22FBU189 ; CDS780119VH, Lot Number 22HBO015 ; CDS780119VH, Lot Number 22KBN442 ; CDS780119VH, Lot Number 23ABF941 ; CDS780119VH, Lot Number 23BBQ326 ; CDS780119VH, Lot Number 23DBE182 ; CDS780119VH, Lot Number 23GBQ904 ; CDS780119VH, Lot Number 23JBS979 ; CDS780119VH, Lot Number 23LBD741 ; CDS780119VH, Lot Number 24ABF767 ; CDS780119VH, Lot Number 24BBK027 ; CDS780147K , Lot Number 19ABP440 ; CDS780147K , Lot Number 19BBK868 ; CDS780147K , Lot Number 19CBL354 ; CDS780147K , Lot Number 19DBN530 ; CDS780148O , Lot Number 19ABX753 ; CDS780148O , Lot Number 19BBU772 ; CDS780148O , Lot Number 19CBP688 ; CDS780165L , Lot Number 19ABF358 ; CDS780165L , Lot Number 19BBR962 ; CDS780165L , Lot Number 19CBK012 ; CDS780165L , Lot Number 19PBA053 ; CDS780165L , Lot Number 19FBQ264 ; CDS780165L , Lot Number 19GBA892 ; CDS780165L , Lot Number 19HBE878 ; CDS780165L , Lot Number 19IBF169 ; CDS780165L , Lot Number 19JBL246 ; CDS780165L , Lot Number 19KBU727 ; CDS780165L , Lot Number 19LBU133 ; CDS780165L , Lot Number 20BBK633 ; CDS780165L , Lot Number 20CBP801 ; CDS780165L , Lot Number 20EBS174 ; CDS780165L , Lot Number 20GBI043 ; CDS780165L , Lot Number 20HBH805 ; CDS780165L , Lot Number 20JBH041 ; CDS780165L , Lot Number 20KBL356 ; CDS780165L , Lot Number 20LBS183 ; CDS780165L , Lot Number 20XBC144 ; CDS780165L , Lot Number 21CBE173 ; CDS780165L , Lot Number 21EBC434 ; CDS780165M , Lot Number 21GBV745 ; CDS780165M , Lot Number 21IBL038 ; CDS780165N , Lot Number 21LBH639 ; CDS780165N , Lot Number 22BBX965 ; CDS780165N , Lot Number 22BBX966 ; CDS780165N , Lot Number 22DBS060 ; CDS780165N , Lot Number 22FBG624 ; CDS780165N , Lot Number 22FBG637 ; CDS780165N , Lot Number 22GBW164 ; CDS780165N , Lot Number 22IBS658 ; CDS780165N , Lot Number 22IBS659 ; CDS780165N , Lot Number 22JBJ077 ; CDS780165N , Lot Number 22KBE478 ; CDS780165N , Lot Number 22LBL139 ; CDS780165O , Lot Number 23BBD144 ; CDS780165O , Lot Number 23CBU486 ; CDS780165O , Lot Number 23FBG448 ; CDS780165Q , Lot Number 23IBD830 ; CDS780165Q , Lot Number 23IBG822 ; CDS780165Q , Lot Number 23JBR705 ; CDS780165R , Lot Number 24ABD703 ; CDS780166Q , Lot Number 21HBA493 ; CDS780166Q , Lot Number 21IBO592 ; CDS780166Q , Lot Number 21IBT365 ; CDS780166Q , Lot Number 19BBK880 ; CDS780166Q , Lot Number 19CBL658 ; CDS780166Q , Lot Number 19DBD742 ; CDS780166Q , Lot Number 19EBU630 ; CDS780166Q , Lot Number 19GBN522 ; CDS780166Q , Lot Number 19HBM045 ; CDS780166Q , Lot Number 19JBP877 ; CDS780166Q , Lot Number 19KBH848 ; CDS780166Q , Lot Number 19LBR657 ; CDS780166Q , Lot Number 20ABF337 ; CDS780166Q , Lot Number 20ABW765 ; CDS780166Q , Lot Number 20CBX811 ; CDS780166Q , Lot Number 20DBK653 ; CDS780166Q , Lot Number 20EBD439 ; CDS780166Q , Lot Number 20EBJ889 ; CDS780166Q , Lot Number 20GBL414 ; CDS780166Q , Lot Number 20GBQ704 ; CDS780166Q , Lot Number 20IBL449 ; CDS780166Q , Lot Number 20IBS281 ; CDS780166Q , Lot Number 20JBY397 ; CDS780166Q , Lot Number 21ABC393 ; CDS780166Q , Lot Number 21ABF535 ; CDS780166Q , Lot Number 21BBM815 ; CDS780166Q , Lot Number 21EBK801 ; CDS780166R , Lot Number 22ABY326 ; CDS780166R , Lot Number 22BBU293 ; CDS780166R , Lot Number 22DBI993 ; CDS780166R , Lot Number 22EBN087 ; CDS780166R , Lot Number 22GBD876 ; CDS780166R , Lot Number 22IBB675 ; CDS780166S , Lot Number 23ABM884 ; CDS780166T , Lot Number 23BBB002 ; CDS780166T , Lot Number 23DBT180 ; CDS780166U , Lot Number 23IBG519 ; CDS780166V , Lot Number 24ABB703 ; CDS780166V , Lot Number 24BBI311 ; CDS780168P , Lot Number 20ABT891 ; CDS780168P , Lot Number 20BBE326 ; CDS780168P , Lot Number 20EBG533 ; CDS780168P , Lot Number 20FBD877 ; CDS780168P , Lot Number 20HBK973 ; CDS780168P , Lot Number 20IBG118 ; CDS780168P , Lot Number 20XBC516 ; CDS780182O , Lot Number 21HBK305 ; CDS780182O , Lot Number 21JBQ826 ; CDS780182O , Lot Number 21VBC538 ; CDS780182O , Lot Number 22ABO087 ; CDS780182O , Lot Number 22ABY371 ; CDS780182O , Lot Number 19ABC655 ; CDS780182O , Lot Number 19EBK417 ; CDS780182O , Lot Number 19FBJ995 ; CDS780182O , Lot Number 22GBK549 ; CDS780182O , Lot Number 19FBN133 ; CDS780182O , Lot Number 22GBU760 ; CDS780182O , Lot Number 19GBZ132 ; CDS780182O , Lot Number 22IBH107 ; CDS780182O , Lot Number 19HBK411 ; CDS780182O , Lot Number 19IBJ480 ; CDS780182O , Lot Number 19KBB216 ; CDS780182O , Lot Number 19KBB367 ; CDS780182O , Lot Number 23BBA103 ; CDS780182O , Lot Number 23BBA104 ; CDS780182O , Lot Number 20ABB930 ; CDS780182O , Lot Number 20ABS653 ; CDS780182O , Lot Number 20BBW916 ; CDS780182O , Lot Number 23HBT871 ; CDS780182O , Lot Number 20EBJ990 ; CDS780182O , Lot Number 23JBO099 ; CDS780182O , Lot Number 20GBB077 ; CDS780182O , Lot Number 20GBQ443 ; CDS780182O , Lot Number 20HBM584 ; CDS780182O , Lot Number 20IBG077 ; CDS780182O , Lot Number 20IBH839 ; CDS780182O , Lot Number 21BBO808 ; CDS780182O , Lot Number 21CBA843 ; CDS780182O , Lot Number 21CBR599 ; CDS780182O , Lot Number 21DBT948 ; CDS780182O , Lot Number 21FBA072 ; CDS780182O , Lot Number 24AMJ450 ; CDS780197N , Lot Number 19FBZ309 ; CDS780197N , Lot Number 19TBB335 ; CDS780197N , Lot Number 19JBU303 ; CDS780197N , Lot Number 19JBW642 ; CDS780197N , Lot Number 20ABF455 ; CDS780197N , Lot Number 20EBG436 ; CDS780197N , Lot Number 20FBF349 ; CDS780197N , Lot Number 20JBQ057 ; CDS780197P , Lot Number 21GBJ220 ; CDS780197P , Lot Number 21GBV773 ; CDS780197P , Lot Number 21IBD859 ; CDS780197P , Lot Number 21IBD860 ; CDS780197P , Lot Number 21IBT378 ; CDS780197P , Lot Number 22CMC380 ; CDS780197P , Lot Number 22DMB205 ; CDS780197P , Lot Number 22DMG876 ; CDS780197P , Lot Number 22EMG726 ; CDS780197P , Lot Number 22HMA252 ; CDS780197P , Lot Number 22JMB503 ; CDS780197P , Lot Number 22KMG561 ; CDS780197P , Lot Number 22LMB708 ; CDS780197P , Lot Number 23BMF112 ; CDS780197P , Lot Number 23BMG487 ; CDS780197Q , Lot Number 23GMG340 ; CDS780197Q , Lot Number 23HME534 ; CDS780197Q , Lot Number 23IME744 ; CDS780201N , Lot Number 19BBE572 ; CDS780201N , Lot Number 19EBN500 ; CDS780201N , Lot Number 19QBB430 ; CDS780201N , Lot Number 20DBM732 ; CDS780201N , Lot Number 20DBT274 ; CDS780201N , Lot Number 20EBJ242 ; CDS780201N , Lot Number 20FBO688 ; CDS780201N , Lot Number 20FBT979 ; CDS780201N , Lot Number 20GBU610 ; CDS780201N , Lot Number 20IBD284 ; CDS780201N , Lot Number 21ABO540 ; CDS780203J , Lot Number 19BBM875 ; CDS780203J , Lot Number 19BBS003 ; CDS780203J , Lot Number 19DBV640 ; CDS780203J , Lot Number 19EBE487 ; CDS780203J , Lot Number 19EBM547 ; CDS780203J , Lot Number 19FBZ922 ; CDS780203J , Lot Number 20DBT297 ; CDS780203J , Lot Number 20EBI661 ; CDS780203J , Lot Number 20GBH759 ; CDS780203J , Lot Number 20GBR700 ; CDS780203J , Lot Number 20HBA716 ; CDS780203J , Lot Number 20HBQ669 ; CDS780203J , Lot Number 20IBF396 ; CDS780204P , Lot Number 19HKB374 ; CDS780204P , Lot Number 19KKA087 ; CDS780204P , Lot Number 19LKA121 ; CDS780204P , Lot Number 20AKA396 ; CDS780204P , Lot Number 20BKA203 ; CDS780204Q , Lot Number 21DMD320 ; CDS780204Q , Lot Number 21FMD248 ; CDS780204Q , Lot Number 21GMA434 ; CDS780204Q , Lot Number 21IMB714 ; CDS780204Q , Lot Number 21JMB144 ; CDS780204Q , Lot Number 21JMF852 ; CDS780204Q , Lot Number 21JMI331 ; CDS780204Q , Lot Number 21LMG913 ; CDS780204Q , Lot Number 22JMG642 ; CDS780204Q , Lot Number 22KMG319 ; CDS780204Q , Lot Number 23DMH775 ; CDS780204Q , Lot Number 23GMC779 ; CDS780204Q , Lot Number 23GMI785 ; CDS780204Q , Lot Number 20HKB814 ; CDS780204Q , Lot Number 20JKA543 ; CDS780204Q , Lot Number 20LKA112 ; CDS780204Q , Lot Number 21AKB175 ; CDS780205O , Lot Number 19BKC139 ; CDS780205P , Lot Number 19HKA583 ; CDS780205P , Lot Number 19JKB108 ; CDS780205P , Lot Number 19KKB462 ; CDS780205P , Lot Number 19KKB600 ; CDS780205P , Lot Number 20CKB378 ; CDS780205Q , Lot Number 21GMF534 ; CDS780205Q , Lot Number 21IME383 ; CDS780205Q , Lot Number 21JMI174 ; CDS780205Q , Lot Number 21KMD719 ; CDS780205Q , Lot Number 21KMH777 ; CDS780205Q , Lot Number 22GMA940 ; CDS780205Q , Lot Number 20EKB234 ; CDS780205Q , Lot Number 20FKA999 ; CDS780205Q , Lot Number 20GKB432 ; CDS780205Q , Lot Number 21AKB227 ; CDS780205Q , Lot Number 21CKA935 ; CDS780206O , Lot Number 19AKB597 ; CDS780206O , Lot Number 19HKB050 ; CDS780206P , Lot Number 19JKB227 ; CDS780206P , Lot Number 20AKA263 ; CDS780206P , Lot Number 20BKA182 ; CDS780206P , Lot Number 20CKA887 ; CDS780206R , Lot Number 20LMB704 ; CDS780206R , Lot Number 21AMB103 ; CDS780206R , Lot Number 21FMB491 ; CDS780206R , Lot Number 21KMF188 ; CDS780206R , Lot Number 21LMC770 ; CDS780206R , Lot Number 22AMC677 ; CDS780206R , Lot Number 22JMG644 ; CDS780206R , Lot Number 22LMD016 ; CDS780206R , Lot Number 23JMI989 ; CDS780206R , Lot Number 20FKB883 ; CDS780207S , Lot Number 19BKC204 ; CDS780207S , Lot Number 19IKA697 ; CDS780207T , Lot Number 21HBT652 ; CDS780207T , Lot Number 21JBS097 ; CDS780207T , Lot Number 21JBS098 ; CDS780207T , Lot Number 21JBZ394 ; CDS780207T , Lot Number 21KBL584 ; CDS780207T , Lot Number 21LBT158 ; CDS780207T , Lot Number 21EBK841 ; CDS780207T , Lot Number 19JKB953 ; CDS780207T , Lot Number 19KKB187 ; CDS780207T , Lot Number 21AKA496 ; CDS780208I , Lot Number 23JBU709 ; CDS780208I , Lot Number 23KBX175 ; CDS780208I , Lot Number 23KBX251 ; CDS780210I , Lot Number 19ALA227 ; CDS780210I , Lot Number 19ALA462 ; CDS780210I , Lot Number 19CLA236 ; CDS780210I , Lot Number 19DLA322 ; CDS780210J , Lot Number 19HLA535 ; CDS780210J , Lot Number 19JLA346 ; CDS780210J , Lot Number 19KLA516 ; CDS780210J , Lot Number 19LLA130 ; CDS780210J , Lot Number 19LLA390 ; CDS780210J , Lot Number 20ALA112 ; CDS780210K , Lot Number 20CLA632 ; CDS780210K , Lot Number 20ELA192 ; CDS780210K , Lot Number 20GLA134 ; CDS780210K , Lot Number 20HLA297 ; CDS780210K , Lot Number 20KLA014 ; CDS780210K , Lot Number 20KLA109 ; CDS780210K , Lot Number 20KLA244 ; CDS780210K , Lot Number 21ALA619 ; CDS780228D , Lot Number 22AMF401 ; CDS780228D , Lot Number 22AMG396 ; CDS780235V , Lot Number 21GBS192 ; CDS780235V , Lot Number 21HBJ876 ; CDS780235V , Lot Number 20JBR059 ; CDS780235V , Lot Number 20KBL944 ; CDS780235V , Lot Number 20LBP116 ; CDS780235V , Lot Number 21BBF829 ; CDS780235W , Lot Number 22BBR030 ; CDS780235W , Lot Number 22FMG272 ; CDS780235W , Lot Number 23AMC001 ; CDS780235W , Lot Number 23BMG083 ; CDS780235X , Lot Number 24AMB219 ; CDS780235X , Lot Number 24AMG280 ; CDS780236L , Lot Number 19CBA983 ; CDS780236L , Lot Number 19EBC887 ; CDS780236L , Lot Number 19EBY014 ; CDS780236L , Lot Number 19FBG017 ; CDS780236L , Lot Number 19LBF072 ; CDS780236L , Lot Number 20FBW672 ; CDS780236L , Lot Number 20GBF806 ; CDS780236L , Lot Number 20GBK506 ; CDS780236L , Lot Number 20GBS537 ; CDS780236L , Lot Number 21ABN771 ; CDS780236M , Lot Number 21JBT003 ; CDS780236M , Lot Number 21KBO564 ; CDS780236M , Lot Number 22NBA858 ; CDS780236M , Lot Number 22CBY062 ; CDS780236M , Lot Number 22FBX199 ; CDS780236M , Lot Number 22GBJ671 ; CDS780236M , Lot Number 22JBB154 ; CDS780236M , Lot Number 22KBC290 ; CDS780237K , Lot Number 19BBQ089 ; CDS780237K , Lot Number 19CBW566 ; CDS780237K , Lot Number 19FBR654 ; CDS780237K , Lot Number 19TBC912 ; CDS780237K , Lot Number 19KBU731 ; CDS780237K , Lot Number 20ABN326 ; CDS780237K , Lot Number 20BBW739 ; CDS780237K , Lot Number 20DBN030 ; CDS780237K , Lot Number 20FBC927 ; CDS780237K , Lot Number 20GBL446 ; CDS780237K , Lot Number 20HBH791 ; CDS780237K , Lot Number 20LBM821 ; CDS780237K , Lot Number 21ABT644 ; CDS780237L , Lot Number 21GBG993 ; CDS780237L , Lot Number 22EBC188 ; CDS780237L , Lot Number 22FBG523 ; CDS780237L , Lot Number 22GBF281 ; CDS780237L , Lot Number 22HBD662 ; CDS780237L , Lot Number 22IBC625 ; CDS780237L , Lot Number 22IBQ954 ; CDS780237L , Lot Number 23CBL694 ; CDS780237L , Lot Number 23CBM721 ; CDS780237L , Lot Number 23CBX580 ; CDS780237L , Lot Number 21DBA637 ; CDS780237L , Lot Number 21FBH222 ; CDS780237L , Lot Number 22BLA857 ; CDS860017AA, Lot Number 19ABP385 ; CDS860017AB, Lot Number 19ABY957 ; CDS860017AB, Lot Number 19CBL317 ; CDS860017AB, Lot Number 19EBK830 ; CDS860017AB, Lot Number 19GBW004 ; CDS860017AB, Lot Number 19SBG481 ; CDS860017AB, Lot Number 19TBD552 ; CDS860017AB, Lot Number 19IBC644 ; CDS860017AB, Lot Number 19IBJ078 ; CDS860017AB, Lot Number 19JBH120 ; CDS860017AB, Lot Number 19VBA707 ; CDS860017AB, Lot Number 19VBC059 ; CDS860017AB, Lot Number 20ABJ934 ; CDS860017AB, Lot Number 20DBD785 ; CDS860017AB, Lot Number 20HBC019 ; CDS860017AB, Lot Number 20HBQ811 ; CDS860017AB, Lot Number 20JBR263 ; CDS860017AB, Lot Number 20XBA403 ; CDS860017AB, Lot Number 21ABM097 ; CDS860017AC, Lot Number 21LBJ666 ; CDS860017AC, Lot Number 22ABF962 ; CDS860017AC, Lot Number 22DBI012 ; CDS860017AC, Lot Number 22GBM024 ; CDS860017AC, Lot Number 22IBA866 ; CDS860017AC, Lot Number 22IBA867 ; CDS860017AC, Lot Number 22IBI049 ; CDS860017AC, Lot Number 23ABA853 ; CDS860017AC, Lot Number 23ABN816 ; CDS860017AC, Lot Number 23BBD149 ; CDS860017AC, Lot Number 23FBN506 ; CDS860017AC, Lot Number 23GBF835 ; CDS860017AC, Lot Number 23GBP215 ; CDS860017AC, Lot Number 23GBS036 ; CDS860017AC, Lot Number 24ABC731 ; CDS860017AC, Lot Number 24ABP257 ; CDS860017AC, Lot Number 21CBF910 ; CDS860138D , Lot Number 19ABQ136 ; CDS860138D , Lot Number 19BBN817 ; CDS860138D , Lot Number 19EBI657 ; CDS860138D , Lot Number 19IBW694 ; CDS860138D , Lot Number 19LBP292 ; CDS860138F , Lot Number 20CBB526 ; CDS860138F , Lot Number 20DBG756 ; CDS860138F , Lot Number 20LBV775 ; CDS860138G , Lot Number 21DBC090 ; CDS860170I , Lot Number 19ABF804 ; CDS860170I , Lot Number 19BBQ437 ; CDS860170J , Lot Number 21GBA985 ; CDS860170J , Lot Number 21IBJ214 ; CDS860170J , Lot Number 21KBB575 ; CDS860170J , Lot Number 21KBU565 ; CDS860170J , Lot Number 21LBN475 ; CDS860170J , Lot Number 19FBN707 ; CDS860170J , Lot Number 19GBL869 ; CDS860170J , Lot Number 19GBN342 ; CDS860170J , Lot Number 22HBW286 ; CDS860170J , Lot Number 19SBB095 ; CDS860170J , Lot Number 22IBE670 ; CDS860170J , Lot Number 22JBH330 ; CDS860170J , Lot Number 19TBC537 ; CDS860170J , Lot Number 22LBC689 ; CDS860170J , Lot Number 19JBE704 ; CDS860170J , Lot Number 23ABC236 ; CDS860170J , Lot Number 23ABK729 ; CDS860170J , Lot Number 19KBQ805 ; CDS860170J , Lot Number 19LBG156 ; CDS860170J , Lot Number 23DBD487 ; CDS860170J , Lot Number 20ABS665 ; CDS860170J , Lot Number 23EBV682 ; CDS860170J , Lot Number 20BBW633 ; CDS860170J , Lot Number 23FBU593 ; CDS860170J , Lot Number 20DBK836 ; CDS860170J , Lot Number 20EBC886 ; CDS860170J , Lot Number 20FBJ566 ; CDS860170J , Lot Number 23JBH129 ; CDS860170J , Lot Number 20GBQ824 ; CDS860170J , Lot Number 20LBR262 ; CDS860170J , Lot Number 21BBM002 ; CDS860170J , Lot Number 21EBC486 ; CDS860170K , Lot Number 23KBS472 ; CDS940047AA, Lot Number 19BDC968 ; CDS940047AA, Lot Number 19DDC046 ; CDS940047AA, Lot Number 19DDC430 ; CDS940047AA, Lot Number 19GDA332 ; CDS940047AA, Lot Number 19HDC228 ; CDS940047AA, Lot Number 19JDC076 ; CDS940047AA, Lot Number 19LDB760 ; CDS940047AA, Lot Number 20CDC265 ; CDS940047AB, Lot Number 20GDA820 ; CDS940047AB, Lot Number 20IDA834 ; CDS940047AB, Lot Number 20KDA177 ; CDS940047AB, Lot Number 20LDA287 ; CDS940047AB, Lot Number 21CDB743 ; CDS940047AC, Lot Number 21FDA359 ; CDS940047AC, Lot Number 21HDA380 ; CDS940047AC, Lot Number 21HDB718 ; CDS940047AC, Lot Number 22CDB855 ; CDS940047AC, Lot Number 22DDA410 ; CDS940047AC, Lot Number 22DDA885 ; CDS940047AC, Lot Number 22EDA610 ; CDS940047AD, Lot Number 22GDB423 ; CDS940047AF, Lot Number 22KDA050 ; CDS940047AF, Lot Number 23BDA010 ; CDS940047AF, Lot Number 23CDB620 ; CDS940047AF, Lot Number 23DDC114 ; CDS940047AF, Lot Number 23FDA378 ; CDS940047AF, Lot Number 23GDB923 ; CDS940047AF, Lot Number 23HDB417 ; CDS940047AF, Lot Number 23IDA521 ; CDS940047AG, Lot Number 23KDA158 ; CDS940047AG, Lot Number 24ADA404 ; CDS940047AI, Lot Number 24BDA533 ; CDS940047AI, Lot Number 24CDA865 ; CDS940047AI, Lot Number 24CDB447 ; CDS940048AB, Lot Number 19BDC637 ; CDS940048AB, Lot Number 19DDA396 ; CDS940048AB, Lot Number 19EDD473 ; CDS940048AB, Lot Number 19IDC112 ; CDS940048AB, Lot Number 19KDA804 ; CDS940048AB, Lot Number 20ADA910 ; CDS940048AB, Lot Number 20CDC240 ; CDS940048AB, Lot Number 20DDB674 ; CDS940048AC, Lot Number 20GDB807 ; CDS940048AC, Lot Number 20IDA861 ; CDS940048AC, Lot Number 20KDB463 ; CDS940048AC, Lot Number 21ADB198 ; CDS940048AC, Lot Number 21CDB557 ; CDS940048AC, Lot Number 21CDC438 ; CDS940048AD, Lot Number 21HDB799 ; CDS940048AD, Lot Number 21HDC479 ; CDS940048AD, Lot Number 21JDB116 ; CDS940048AF, Lot Number 22EDB749 ; CDS940048AG, Lot Number 22IDA258 ; CDS940048AG, Lot Number 22JDB464 ; CDS940048AG, Lot Number 23BDA005 ; CDS940048AG, Lot Number 23CDA075 ; CDS940048AG, Lot Number 23CDB146 ; CDS940048AG, Lot Number 23FDA460 ; CDS940048AG, Lot Number 23HDA534 ; CDS940048AG, Lot Number 23IDA944 ; CDS940048AI, Lot Number 23KDA886 ; CDS940048AI, Lot Number 24ADA827 ; CDS940060AA, Lot Number 19BBJ734 ; CDS940060AA, Lot Number 19BBU037 ; CDS940060AA, Lot Number 19DBD751 ; CDS940060AB, Lot Number 19EBT410 ; CDS940060AB, Lot Number 19FBD674 ; CDS940060AB, Lot Number 19GBM852 ; CDS940060AB, Lot Number 19TBE517 ; CDS940060AB, Lot Number 19IBX513 ; CDS940060AC, Lot Number 19KBI891 ; CDS940060AC, Lot Number 19LBT074 ; CDS940060AC, Lot Number 20ABO601 ; CDS940060AD, Lot Number 20DBB480 ; CDS940060AD, Lot Number 20FBT722 ; CDS940060AD, Lot Number 20JBH314 ; CDS940060AD, Lot Number 20LBF231 ; CDS940060AF, Lot Number 21BBI970 ; CDS940060AG, Lot Number 21FBK160 ; CDS940060AG, Lot Number 21GBR899 ; CDS940060AG, Lot Number 21GBR900 ; CDS940060AG, Lot Number 21JBF924 ; CDS940060AG, Lot Number 21KBH178 ; CDS940060AG, Lot Number 22FBB236 ; CDS940060AG, Lot Number 22FBG732 ; CDS940060AG, Lot Number 22GBI847 ; CDS940060AG, Lot Number 21DBM270 ; CDS940060AI, Lot Number 22HBS769 ; CDS940060AI, Lot Number 22JBU536 ; CDS940060AI, Lot Number 22KBG389 ; CDS940060AI, Lot Number 22LBE929 ; CDS940060AI, Lot Number 23ABG372 ; CDS940060AI, Lot Number 23CBM507 ; CDS940060AI, Lot Number 23CBU504 ; CDS940060AI, Lot Number 23EBD027 ; CDS940060AI, Lot Number 23FBF613 ; CDS940060AI, Lot Number 23FBP578 ; CDS940060AI, Lot Number 23IBD724 ; CDS940060AI, Lot Number 23IBQ758 ; CDS940060AI, Lot Number 23KBT052 ; CDS940064Q , Lot Number 19CBJ837 ; CDS940064Q , Lot Number 19DBL652 ; CDS940064Q , Lot Number 19QBB889 ; CDS940064Q , Lot Number 19GBG892 ; CDS940064Q , Lot Number 19HBE965 ; CDS940064Q , Lot Number 19IBP862 ; CDS940064Q , Lot Number 19IBS356 ; CDS940064Q , Lot Number 19VBB936 ; CDS940064Q , Lot Number 19VBH131 ; CDS940064Q , Lot Number 19KBQ727 ; CDS940080T , Lot Number 21HBR427 ; CDS940080T , Lot Number 21IBL992 ; CDS940080T , Lot Number 22ABF188 ; CDS940080T , Lot Number 22BBB799 ; CDS940080T , Lot Number 19CBA003 ; CDS940080T , Lot Number 19CBR575 ; CDS940080T , Lot Number 22DBJ461 ; CDS940080T , Lot Number 22DBM767 ; CDS940080T , Lot Number 19PBC872 ; CDS940080T , Lot Number 22GBO450 ; CDS940080T , Lot Number 19GBA676 ; CDS940080T , Lot Number 19IBT426 ; CDS940080T , Lot Number 20ABY918 ; CDS940080T , Lot Number 20BBP131 ; CDS940080T , Lot Number 20DBQ011 ; CDS940080T , Lot Number 20GBJ660 ; CDS940080T , Lot Number 21ABK429 ; CDS940080T , Lot Number 21ABS987 ; CDS940080T , Lot Number 21BBG965 ; CDS940080T , Lot Number 21EBH619 ; CDS940080U , Lot Number 22JBJ442 ; CDS940080V , Lot Number 23CBG228 ; CDS940080V , Lot Number 23EBD087 ; CDS940080W , Lot Number 23EBV659 ; CDS940080W , Lot Number 23KBB662 ; CDS940080W , Lot Number 23KBX234 ; CDS940087AC, Lot Number 20ABC867 ; CDS940087AC, Lot Number 20ABU027 ; CDS940087AC, Lot Number 20DBM203 ; CDS940087AC, Lot Number 20FBT720 ; CDS940087AC, Lot Number 20HBE580 ; CDS940087AC, Lot Number 20HBV401 ; CDS940087AD, Lot Number 20KBE315 ; CDS940087AD, Lot Number 20LBU707 ; CDS940087AG, Lot Number 21EBC900 ; CDS940087AI, Lot Number 21GBI183 ; CDS940087AI, Lot Number 21IBJ260 ; CDS940087AI, Lot Number 21JBF936 ; CDS940087AI, Lot Number 21KBH163 ; CDS940087AI, Lot Number 22BBY060 ; CDS940087AI, Lot Number 22EBA274 ; CDS940087AI, Lot Number 22EBF695 ; CDS940087AI, Lot Number 22EBG548 ; CDS940087AI, Lot Number 22GBE442 ; CDS940087AJ, Lot Number 22HBO525 ; CDS940087AK, Lot Number 22LBG216 ; CDS940087AL, Lot Number 23ABB068 ; CDS940087AL, Lot Number 23DBN024 ; CDS940087AL, Lot Number 23EBL944 ; CDS940087AL, Lot Number 23FBI843 ; CDS940087AL, Lot Number 23HBP378 ; CDS940087AL, Lot Number 23IBD027 ; CDS940087AL, Lot Number 23IBW076 ; CDS940087AL, Lot Number 23KBN905 ; CDS940087AL, Lot Number 23KBP002 ; CDS940088M , Lot Number 19BBU013 ; CDS940088M , Lot Number 19HBQ641 ; CDS940088M , Lot Number 19HBZ093 ; CDS940088M , Lot Number 19IBX779 ; CDS940088M , Lot Number 19VBA573 ; CDS940091Q , Lot Number 19PBA068 ; CDS940218L , Lot Number 21LBO374 ; CDS940218L , Lot Number 22BBF255 ; CDS940218L , Lot Number 22CBC343 ; CDS940218L , Lot Number 22DBK722 ; CDS940218L , Lot Number 22GBB125 ; CDS940218L , Lot Number 19FBJ791 ; CDS940218L , Lot Number 22HBF657 ; CDS940218L , Lot Number 22HBS730 ; CDS940218L , Lot Number 19KBC397 ; CDS940218L , Lot Number 20BBA602 ; CDS940218L , Lot Number 20BBW907 ; CDS940218L , Lot Number 20GBS036 ; CDS940218L , Lot Number 20IBL823 ; CDS940218M , Lot Number 23FBD940 ; CDS940242J , Lot Number 22FBH313 ; CDS940242J , Lot Number 22GBT200 ; CDS940242J , Lot Number 22JBC106 ; CDS940242J , Lot Number 23ABE598 ; CDS940242J , Lot Number 23ABF766 ; CDS940242J ,

Distribution pattern

Worldwide distribution.

device · product 73 of 81

Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702

Z-3053-2024
Recall number
Z-3053-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

613034700, Lot Number 20ADD340 ; 613034700, Lot Number 20BDC393 ; 613034700, Lot Number 20BDC472 ; 613034700, Lot Number 20BDC473 ; 613034700, Lot Number 20FDA390 ; 613034700, Lot Number 20FDA896 ; 613034700, Lot Number 20FDA897 ; 613034700, Lot Number 20FDA898 ; 613034700, Lot Number 20FDA896A; 613034700, Lot Number 20JDB120 ; 613034700, Lot Number 21CDA660 ; 613034700, Lot Number 21DDB193 ; 613034700, Lot Number 21IDA396 ; 613034700, Lot Number 21LDB900 ; 613034700, Lot Number 22ADB549 ; 613034701, Lot Number 21CDA617 ; 613034701, Lot Number 21DDB192 ; 613034701, Lot Number 21IDB791 ; 613034701, Lot Number 21JDB094 ; 613034701, Lot Number 22BDB700 ; 613034702, Lot Number 21CDA618 ; 613034702, Lot Number 21DDB222 ; 613034702, Lot Number 21IDB804 ; 613034702, Lot Number 21LDB713

Distribution pattern

Worldwide distribution.

device · product 74 of 81

Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number CDS985508D ; 39) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 40) ARTHROGRAM TRAY , Pack Number DYNDH1134; 41) ARTHROGRAM TRAY , Pack Number DYNDH1243; 42) ARTHROGRAM PACK , Pack Number DYNDH1322; 43) ARTHROGRAM TRAY , Pack Number DYNDH1347; 44) ARTHROGRAM TRAY , Pack Number DYNDH1349; 45) ARTHROGRAM PACK , Pack Number DYNDH1350; 46) BEACH CHAIR SHOULDER PACK-LF, Pack Number DYNJ00040K ; 47) ARTHROGRAM PACK-LF, Pack Number DYNJ0101275A ; 48) ARTHROSCOPY PACK-LF , Pack Number DYNJ0101722C ; 49) ARTHROSCOPY PACK-LF , Pack Number DYNJ0103045G ; 50) ARTHROSCOPY LV - EDOC PACK-LF , Pack Number DYNJ0111409L ; 51) ARTHROSCOPY PACK-LF , Pack Number DYNJ01114D ; 52) ARTHROSCOPY II PACK-LF, Pack Number DYNJ0161097B ; 53) ARTHROSCOPY PACK, Pack Number DYNJ01829F ; 54) ARTHROSCOPY PACK-LF , Pack Number DYNJ0190768L ; 55) ARTHROSCOPY PACK-LF , Pack Number DYNJ0200295Q ; 56) ARTHROSCOPY PACK-LF , Pack Number DYNJ0219853Q ; 57) YUMH/SURGI-CENTER ARTHRO PK-LF, Pack Number DYNJ0244761K ; 58) ARTHRO KNEE PACK, Pack Number DYNJ02579F ; 59) ARTHROSCOPY PACK-LF , Pack Number DYNJ0281409O ; 60) PPSC ARTHROSCOPY PACK-LF, Pack Number DYNJ0303231D ; 61) ARTHROSCOPY PACK-LF , Pack Number DYNJ0365867L ; 62) ARTHROSCOPY PACK-LF , Pack Number DYNJ0366488I ; 63) ARTHROSCOPY PACK-LF , Pack Number DYNJ0373216K ; 64) ARTHROSCOPY PACK-LF , Pack Number DYNJ0373876F ; 65) ARTHROSCOPY PACK-LF , Pack Number DYNJ0374577N ; 66) ARTHROSCOPY PACK-LF , Pack Number DYNJ0376528J ; 67) ARTHROSCOPY PACK-LF , Pack Number DYNJ0377096D ; 68) ARTHROSCOPY PACK-LF , Pack Number DYNJ0378266K ; 69) ARTHROSCOPY PACK-LF , Pack Number DYNJ0382618L ; 70) ARTHROSCOPY PACK-LF , Pack Number DYNJ0390808F ; 71) ARTHROSCOPY PACK-LF , Pack Number DYNJ0399877G ; 72) ARTHROSCOPY PACK-LF , Pack Number DYNJ0406086L ; 73) ARTHROSCOPY PACK-LF , Pack Number DYNJ0410034P ; 74) GYN RESECTOSCOPE PACK-LF, Pack Number DYNJ0415339I ; 75) ARTHROSCOPY PROCEDURE PACK-LF , Pack Number DYNJ0415915I ; 76) ARTHROSCOPY PACK, Pack Number DYNJ04159A ; 77) ARTHROSCOPY PACK-LF , Pa

Z-3054-2024
Recall number
Z-3054-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

00-399027M , Lot Number 19GLA310 ; 00-399027M , Lot Number 19KLA520 ; 00-399027M , Lot Number 19LLA487 ; 00-399027M , Lot Number 20LLA663 ; 00-399027M , Lot Number 21JLA024 ; 00-399027M , Lot Number 21KLA330 ; 00-399027M , Lot Number 22GLA379 ; 00-399027M , Lot Number 22HLA991 ; 00-399027M , Lot Number 23FLA497 ; 00-399027M , Lot Number 23GLA579 ; CDS940242I , Lot Number 19BBK957 ; CDS940242I , Lot Number 19KBO521 ; CDS940242I , Lot Number 20ABP687 ; CDS940242I , Lot Number 20BBW841 ; CDS940242I , Lot Number 20EBC100 ; CDS940242I , Lot Number 20EBD870 ; CDS940242I , Lot Number 20EBI718 ; CDS940242I , Lot Number 21BBM845 ; CDS940242I , Lot Number 21DBU612 ; CDS940859J , Lot Number 19BBN781 ; CDS940859J , Lot Number 19CBI613 ; CDS940859J , Lot Number 19DBF963 ; CDS940859J , Lot Number 19FBF630 ; CDS940859J , Lot Number 19FBZ846 ; CDS940859J , Lot Number 19KBX776 ; CDS940859J , Lot Number 20ABJ911 ; CDS940859J , Lot Number 20ABX308 ; CDS940859J , Lot Number 20DBB231 ; CDS940869U , Lot Number 22JBA443 ; 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DYNJ01114D , Lot Number 19JBT628 ; DYNJ01114D , Lot Number 19JBX647 ; DYNJ01114D , Lot Number 19KBJ832 ; DYNJ01114D , Lot Number 20CBR158 ; DYNJ01114D , Lot Number 20DBS852 ; DYNJ01114D , Lot Number 20EBB157 ; DYNJ01114D , Lot Number 20EBD934 ; DYNJ0161097B , Lot Number 19DDB777 ; DYNJ0161097B , Lot Number 19EDD576 ; DYNJ0161097B , Lot Number 19GDB741 ; DYNJ0161097B , Lot Number 19HDD021 ; DYNJ01829F , Lot Number 20KMD211 ; DYNJ01829F , Lot Number 20KMD824 ; DYNJ01829F , Lot Number 21FMB041 ; DYNJ01829F , Lot Number 21FMF159 ; DYNJ01829F , Lot Number 19DKC973 ; DYNJ01829F , Lot Number 19HKA549 ; DYNJ01829F , Lot Number 19HKC814 ; DYNJ01829F , Lot Number 19JKA508 ; DYNJ01829F , Lot Number 20BKA232 ; DYNJ01829F , Lot Number 20EKA819 ; DYNJ01829F , Lot Number 20HKA901 ; DYNJ01829F , Lot Number 20JKA225 ; DYNJ0190768L , Lot Number 19AKD551 ; DYNJ0190768L , Lot Number 19DKB600 ; DYNJ0200295Q , Lot Number 20KMB552 ; DYNJ0200295Q , Lot Number 21GMF321 ; DYNJ0200295Q , Lot Number 21HMD880 ; DYNJ0200295Q , Lot Number 21IMA668 ; DYNJ0200295Q , Lot Number 21IME689 ; DYNJ0200295Q , Lot Number 21LMD904 ; DYNJ0200295Q , Lot Number 22DMH580 ; DYNJ0200295Q , Lot Number 22FMG925 ; DYNJ0200295Q , Lot Number 22JMG294 ; DYNJ0200295Q , Lot Number 22LMF261 ; DYNJ0200295Q , Lot Number 23AMJ544 ; DYNJ0200295Q , Lot Number 23AMJ676 ; DYNJ0200295Q , Lot Number 23HMF788 ; DYNJ0200295Q , Lot Number 23IMC574 ; DYNJ0200295Q , Lot Number 23JMC510 ; DYNJ0200295Q , Lot Number 23JMH637 ; DYNJ0200295Q , Lot Number 19BKA348 ; DYNJ0200295Q , Lot Number 19DKA996 ; DYNJ0200295Q , Lot Number 19FKB849 ; DYNJ0200295Q , Lot Number 19GKB069 ; DYNJ0200295Q , Lot Number 19IKB398 ; DYNJ0200295Q , Lot Number 19KKB328 ; DYNJ0200295Q , Lot Number 19LKA295 ; DYNJ0200295Q , Lot Number 20BKA134 ; DYNJ0200295Q , Lot Number 20EKA112 ; DYNJ0200295Q , Lot Number 20FKC120 ; DYNJ0200295Q , Lot Number 20HKB197 ; DYNJ0219853Q , Lot Number 18LBQ194 ; DYNJ0219853Q , Lot Number 19BBE679 ; DYNJ0219853Q , Lot Number 19CBB990 ; DYNJ0219853Q , Lot Number 19CBO317 ; DYNJ0219853Q , Lot Number 19EBS193 ; DYNJ0219853Q , Lot Number 19GBI293 ; DYNJ0219853Q , Lot Number 19IBS921 ; DYNJ0244761K , Lot Number 19ABV992 ; DYNJ0244761K , Lot Number 19CBD333 ; DYNJ0244761K , Lot Number 19DMA067 ; DYNJ0244761K , Lot Number 19EMA076 ; DYNJ0244761K , Lot Number 19FMA161 ; DYNJ0244761K , Lot Number 19GMA505 ; DYNJ0244761K , Lot Number 19IMB241 ; DYNJ0244761K , Lot Number 19KMA882 ; DYNJ0244761K , Lot Number 19LMB762 ; DYNJ0244761K , Lot Number 20AMD099 ; DYNJ0244761K , Lot Number 20FMC163 ; DYNJ0244761K , Lot Number 20KME131 ; DYNJ0244761K , Lot Number 21AME114 ; DYNJ0244761K , Lot Number 21DMA081 ; DYNJ0244761K , Lot Number 21FMF834 ; DYNJ0244761K , Lot Number 21HMH023 ; DYNJ0244761K , Lot Number 21KMG339 ; DYNJ0244761K , Lot Number 21LMB334 ; DYNJ02579F , Lot Number 19ADB888 ; DYNJ02579F , Lot Number 19EDB248 ; DYNJ02579F , Lot Number 19HDD427 ; DYNJ02579F , Lot Number 20ADB761 ; DYNJ02579F , Lot Number 20EDB691 ; DYNJ02579F , Lot Number 20GDA896 ; DYNJ02579F , Lot Number 21ADB144 ; DYNJ02579F , Lot Number 21BDB596 ; DYNJ0281409O , Lot Number 19PBA695 ; DYNJ0281409O , Lot Number 19EBX788 ; DYNJ0281409O , Lot Number 19GBF244 ; DYNJ0281409O , Lot Number 19SBD662 ; DYNJ0281409O , Lot Number 20ABU325 ; DYNJ0281409O , Lot Number 20CBK648 ; DYNJ0281409O , Lot Number 20EBG811 ; DYNJ0281409O , Lot Number 20HBG440 ; DYNJ0281409O , Lot Number 20JBW094 ; DYNJ0281409O , Lot Number 20WBH768 ; DYNJ0281409O , Lot Number 21BBM082 ; DYNJ0281409O , Lot Number 21CBV598 ; DYNJ0281409O , Lot Number 21HMB810 ; DYNJ0281409O , Lot Number 21IMH542 ; DYNJ0281409O , Lot Number 21KMA792 ; DYNJ0281409O , Lot Number 21LMD446 ; DYNJ0281409O , Lot Number 22EMA405 ; DYNJ0281409O , Lot Number 22GMA118 ; DYNJ0281409O , Lot Number 22HME252 ; DYNJ0281409O , Lot Number 22JMF179 ; DYNJ0281409O , Lot Number 23AMA033 ; DYNJ0281409O , Lot Number 23BMI442 ; DYNJ0281409O , Lot Number 23DMG322 ; DYNJ0281409O , Lot Number 23FMA847 ; DYNJ0281409O , Lot Number 23GMD120 ; DYNJ0281409O , Lot Number 23KMD873 ; DYNJ0281409O , Lot Number 19AKA399 ; DYNJ0281409O , Lot Number 19BKA948 ; DYNJ0281409O , Lot Number 19CKB549 ; DYNJ0281409O , Lot Number 19DKC340 ; DYNJ0303231D , Lot Number 19EBJ079 ; DYNJ0303231D , Lot Number 19FBD770 ; DYNJ0365867L , Lot Number 19FKA373 ; DYNJ0365867L , Lot Number 19FKC155 ; DYNJ0365867L , Lot Number 19GKB378 ; DYNJ0366488I , Lot Number 19AKB950 ; DYNJ0366488I , Lot Number 19DKA882 ; DYNJ0366488I , Lot Number 19HKB013 ; DYNJ0373216K , Lot Number 19CKB481 ; DYNJ0373216K , Lot Number 19DKA366 ; DYNJ0373216K , Lot Number 19DKC303 ; DYNJ0373216K , Lot Number 20CKA409 ; DYNJ0373876F , Lot Number 19BBQ527 ; DYNJ0374577N , Lot Number 19BKC022 ; DYNJ0374577N , Lot Number 19DKC719 ; DYNJ0374577N , Lot Number 19EKC779 ; DYNJ0376528J , Lot Number 21GBN057 ; DYNJ0376528J , Lot Number 21IBV289 ; DYNJ0376528J , Lot Number 22DBN024 ; DYNJ0376528J , Lot Number 22JBJ567 ; DYNJ0376528J , Lot Number 23DBJ193 ; DYNJ0376528J , Lot Number 23DBS737 ; DYNJ0376528J , Lot Number 21FBC451 ; DYNJ0376528J , Lot Number 19AKA129 ; DYNJ0376528J , Lot Number 19DKA451 ; DYNJ0376528J , Lot Number 19DKC871 ; DYNJ0376528J , Lot Number 19FKA524 ; DYNJ0376528J , Lot Number 19FKA550 ; DYNJ0376528J , Lot Number 19HKC466 ; DYNJ0376528J , Lot Number 19LKA133 ; DYNJ0376528J , Lot Number 19LKB524 ; DYNJ0376528J , Lot Number 20AKA833 ; DYNJ0376528J , Lot Number 20BKB128 ; DYNJ0376528J , Lot Number 20DKB296 ; DYNJ0376528J , Lot Number 20HKA941 ; DYNJ0376528J , Lot Number 20JKA398 ; DYNJ0376528J , Lot Number 20JKB411 ; DYNJ0376528J , Lot Number 21AKA085 ; DYNJ0376528J , Lot Number 21CKA719 ; DYNJ0377096D , Lot Number 19AKA257 ; DYNJ0377096D , Lot Number 19BKD685 ; DYNJ0377096D , Lot Number 19EKB301 ; DYNJ0378266K , Lot Number 19ABR639 ; DYNJ0378266K , Lot Number 19BBO455 ; DYNJ0378266K , Lot Number 19EBQ005 ; DYNJ0382618L , Lot Number 19DBU193 ; DYNJ0382618L , Lot Number 19DBU671 ; DYNJ0382618L , Lot Number 19EBH877 ; DYNJ0382618L , Lot Number 19GBR136 ; DYNJ0382618L , Lot Number 19HBX908 ; DYNJ0382618L , Lot Number 19IBL709 ; DYNJ0382618L , Lot Number 19KBW565 ; DYNJ0382618L , Lot Number 20CBU551 ; DYNJ0382618L , Lot Number 20CBZ443 ; DYNJ0382618L , Lot Number 20FBT962 ; DYNJ0390808F , Lot Number 20JME801 ; DYNJ0390808F , Lot Number 20KMC937 ; DYNJ0390808F , Lot Number 21FMB331 ; DYNJ0390808F , Lot Number 21GMD003 ; DYNJ0390808F , Lot Number 21IME410 ; DYNJ0390808F , Lot Number 21JMG164 ; DYNJ0390808F , Lot Number 22AMG201 ; DYNJ0390808F , Lot Number 19CKB207 ; DYNJ0390808F , Lot Number 19EKA203 ; DYNJ0390808F , Lot Number 19FKB594 ; DYNJ0390808F , Lot Number 19GKA451 ; DYNJ0390808F , Lot Number 19GKC419 ; DYNJ0390808F , Lot Number 19HKC831 ; DYNJ0390808F , Lot Number 19JKA858 ; DYNJ0390808F , Lot Number 20AKB108 ; DYNJ0390808F , Lot Number 20CKB394 ; DYNJ0390808F , Lot Number 20GKB692 ; DYNJ0390808F , Lot Number 20IKA106 ; DYNJ0399877G , Lot Number 19DBE636 ; DYNJ0399877G , Lot Number 19GBC322 ; DYNJ0406086L , Lot Number 19BBG855 ; DYNJ0406086L , Lot Number 19DBB444 ; DYNJ0406086L , Lot Number 19GBR774 ; DYNJ0406086L , Lot Number 19KBA112 ; DYNJ0406086L , Lot Number 19KBE516 ; DYNJ0406086L , Lot Number 20JMA072 ; DYNJ0406086L , Lot Number 20JMA864 ; DYNJ0406086L , Lot Number 20JMB630 ; DYNJ0406086L , Lot Number 20KMD911 ; DYNJ0406086L , Lot Number 21EMC088 ; DYNJ0406086L , Lot Number 21FMB242 ; DYNJ0406086L , Lot Number 21HMA663 ; DYNJ0406086L , Lot Number 21IMA651 ; DYNJ0406086L , Lot Number 21JMD351 ; DYNJ0406086L , Lot Number 21KME743 ; DYNJ0406086L , Lot Number 21KMH763 ; DYNJ0406086L , Lot Number 21LMF304 ; DYNJ0406086L , Lot Number 22AME916 ; DYNJ0406086L , Lot Number 22BMG310 ; DYNJ0406086L , Lot Number 22EMB048 ; DYNJ0410034P , Lot Number 21KBG426 ; DYNJ0410034P , Lot Number 21KBT119 ; DYNJ0410034P , Lot Number 21LBE587 ; DYNJ0410034P , Lot Number 21LBU322 ; DYNJ0410034P , Lot Number 19ABE779 ; DYNJ0410034P , Lot Number 22BBS106 ; DYNJ0410034P , Lot Number 22OBI855 ; DYNJ0410034P , Lot Number 19DBB115 ; DYNJ0410034P , Lot Number 19DBR411 ; DYNJ0410034P , Lot Number 22EBS318 ; DYNJ0410034P , Lot Number 19GBT335 ; DYNJ0410034P , Lot Number 22JBS300 ; DYNJ0410034P , Lot Number 19IBF033 ; DYNJ0410034P , Lot Number 19KBG956 ; DYNJ0410034P , Lot Number 23BBH572 ; DYNJ0410034P , Lot Number 23CBE241 ; DYNJ0410034P , Lot Number 20ABB139 ; DYNJ0410034P , Lot Number 23DBK506 ; DYNJ0410034P , Lot Number 20CBQ395 ; DYNJ0410034P , Lot Number 23HBO744 ; DYNJ0410034P , Lot Number 20DBS560 ; DYNJ0410034P , Lot Number 20DBT607 ; DYNJ0410034P , Lot Number 20EBB169 ; DYNJ0410034P , Lot Number 20EBF329 ; DYNJ0410034P , Lot Number 20KBH446 ; DYNJ0410034P , Lot Number 20XBG825 ; DYNJ0410034P , Lot Number 21ABP845 ; DYNJ0410034P , Lot Number 21BBJ930 ; DYNJ0410034P , Lot Number 21CBZ868 ; DYNJ0410034P , Lot Number 21DBR941 ; DYNJ0415339I , Lot Number 19AKD426 ; DYNJ0415339I , Lot Number 19CKB076 ; DYNJ0415339I , Lot Number 19DKC342 ; DYNJ0415339I , Lot Number 19FKC707 ; DYNJ0415915I , Lot Number 19DBZ071 ; DYNJ0415915I , Lot Number 19FBJ552 ; DYNJ0415915I , Lot Number 19AKB500 ; DYNJ0415915I , Lot Number 19BKD377 ; DYNJ0415915I , Lot Number 19DKA693 ; DYNJ04159A , Lot Number 19ADA173 ; DYNJ04159A , Lot Number 19ADC853 ; DYNJ04159A , Lot Number 19BDB579 ; DYNJ04159A , Lot Number 19BDD213 ; DYNJ04159A , Lot Number 19CDB589 ; DYNJ0428670I , Lot Number 19BKB580 ; DYNJ0428670I , Lot Number 19DKB811 ; DYNJ04368M , Lot Number 19AKC886 ; DYNJ04368M , Lot Number 19BKC628 ; DYNJ04368M , Lot Number 19CKC779 ; DYNJ04368M , Lot Number 19EKA313 ; DYNJ04368M , Lot Number 19FKA968 ; DYNJ04446N , Lot Number 19IMA129 ; DYNJ04446N , Lot Number 19JMA511 ; DYNJ04446N , Lot Number 20AMA357 ; DYNJ04446N , Lot Number 20BMA993 ; DYNJ04446N , Lot Number 20FMB755 ; DYNJ04446N , Lot Number 20IMC595 ; DYNJ04446N , Lot Number 21AMC149 ; DYNJ04446N , Lot Number 21BMB386 ; DYNJ04446N , Lot Number 21CMB899 ; DYNJ04446N , Lot Number 21DMA455 ; DYNJ04446N , Lot Number 21EMD779 ; DYNJ04446N , Lot Number 21GME661 ; DYNJ04446N , Lot Number 21IMB966 ; DYNJ04446N , Lot Number 21JMG208 ; DYNJ04446N , Lot Number 22AMB353 ; DYNJ04446N , Lot Number 22BMH364 ; DYNJ04446N , Lot Number 22DMC607 ; DYNJ04446N , Lot Number 22EMC123 ; DYNJ04446N , Lot Number 22GMA228 ; DYNJ04446N , Lot Number 22HMG756 ; DYNJ04446N , Lot Number 22JMH875 ; DYNJ04446N , Lot Number 22LMI668 ; DYNJ04446N , Lot Number 22LMI676 ; DYNJ04446N , Lot Number 23CMC911 ; DYNJ04446N , Lot Number 23EMB605 ; DYNJ04446N , Lot Number 23GMA775 ; DYNJ04446N , Lot Number 23IMB617 ; DYNJ04446N , Lot Number 23KMD423 ; DYNJ04446N , Lot Number 19BKA514 ; DYNJ04446N , Lot Number 19CKC240 ; DYNJ04446N , Lot Number 19EKC683 ; DYNJ04446N , Lot Number 19GKC456 ; DYNJ04452K , Lot Number 19JMA045 ; DYNJ04452K , Lot Number 19KMA075 ; DYNJ04452K , Lot Number 19LMC674 ; DYNJ04452K , Lot Number 20AMB490 ; DYNJ04452K , Lot Number 20HMC007 ; DYNJ04452K , Lot Number 20KMD590 ; DYNJ04452K , Lot Number 20LMC624 ; DYNJ04452K , Lot Number 21JMG163 ; DYNJ04452K , Lot Number 19DKA579 ; DYNJ04452K , Lot Number 19EKA039 ; DYNJ04452K , Lot Number 19EKC474 ; DYNJ04452K , Lot Number 19IKB173 ; DYNJ0457300B , Lot Number 21GBF338 ; DYNJ0457300B , Lot Number 21IBE800 ; DYNJ0457300B , Lot Number 21JBB232 ; DYNJ0457300B , Lot Number 21KBQ055 ; DYNJ0457300B , Lot Number 22ABE897 ; DYNJ0457300B , Lot Number 19ABH949 ; DYNJ0457300B , Lot Number 19ABV770 ; DYNJ0457300B , Lot Number 19BBP439 ; DYNJ0457300B , Lot Number 22DBT460 ; DYNJ0457300B , Lot Number 22FBE219 ; DYNJ0457300B , Lot Number 19FBF814 ; DYNJ0457300B , Lot Number 22HBV239 ; DYNJ0457300B , Lot Number 19GBY900 ; DYNJ0457300B , Lot Number 22JBI020 ; DYNJ0457300B , Lot Number 19UBA791 ; DYNJ0457300B , Lot Number 23ABO663 ; DYNJ0457300B , Lot Number 19KBL342 ; DYNJ0457300B , Lot Number 19KBY271 ; DYNJ0457300B , Lot Number 23CBX281 ; DYNJ0457300B , Lot Number 23EBP176 ; DYNJ0457300B , Lot Number 23EBP576 ; DYNJ0457300B , Lot Number 20BBL023 ; DYNJ0457300B , Lot Number 23GBH205 ; DYNJ0457300B , Lot Number 23IBI778 ; DYNJ0457300B , Lot Number 20FBE580 ; DYNJ0457300B , Lot Number 20GBQ558 ; DYNJ0457300B , Lot Number 20JBU316 ; DYNJ0457300B , Lot Number 21ABL801 ; DYNJ0457300B , Lot Number 21CBB809 ; DYNJ0457300B , Lot Number 21OBA381 ; DYNJ04612F , Lot Number 19IMA482 ; DYNJ04612F , Lot Number 19KMB066 ; DYNJ04612F , Lot Number 20EMB493 ; DYNJ04612F , Lot Number 20HMC923 ; DYNJ04612F , Lot Number 20HMC929 ; DYNJ04612F , Lot Number 21AMB226 ; DYNJ04612F , Lot Number 21HME254 ; DYNJ04612F , Lot Number 19AKD268 ; DYNJ04612F , Lot Number 19CKC952 ; DYNJ04612F , Lot Number 19EKC059 ; DYNJ04612F , Lot Number 19GKB703 ; DYNJ04618K , Lot Number 19IMA693 ; DYNJ04618K , Lot Number 19KMB702 ; DYNJ04618K , Lot Number 20AMC218 ; DYNJ04618K , Lot Number 20BMB727 ; DYNJ04618K , Lot Number 20FMA902 ; DYNJ04618K , Lot Number 20GMB243 ; DYNJ04618K , Lot Number 20GMC279 ; DYNJ04618K , Lot Number 19BKC922 ; DYNJ04618K , Lot Number 19DKB692 ; DYNJ04618K , Lot Number 19EKC820 ; DYNJ04618K , Lot Number 19GKA979 ; DYNJ04618K , Lot Number 19HKC664 ; DYNJ04633D , Lot Number 19JMA643 ; DYNJ04633D , Lot Number 20AMC008 ; DYNJ04633D , Lot Number 20HMD343 ; DYNJ04633D , Lot Number 20IMB330 ; DYNJ04759I , Lot Number 19KMA342 ; DYNJ04759I , Lot Number 19LMC670 ; DYNJ04759I , Lot Number 20AMC992 ; DYNJ04759I , Lot Number 19BKB083 ; DYNJ04759I , Lot Number 19CKC625 ; DYNJ04759I , Lot Number 19FKA684 ; DYNJ04759I , Lot Number 19HKC309 ; DYNJ04818D , Lot Number 19IMA606 ; DYNJ04818D , Lot Number 19KMA091 ; DYNJ04818D , Lot Number 20AMC991 ; DYNJ04818D , Lot Number 19AKD637 ; DYNJ04818D , Lot Number 19EKA167 ; DYNJ04818D , Lot Number 19GKD075 ; DYNJ04848M , Lot Number 19AKA887 ; DYNJ04848M , Lot Number 19DKB609 ; DYNJ04848M , Lot Number 19HKC990 ; DYNJ04848M , Lot Number 20AKA242 ; DYNJ04858O , Lot Number 19EKC037 ; DYNJ04858O , Lot Number 19GKC043 ; DYNJ04858O , Lot Number 19HKA900 ; DYNJ04858O , Lot Number 19HKC380 ; DYNJ04858O , Lot Number 19IKB042 ; DYNJ04874L , Lot Number 19JMA678 ; DYNJ04874L , Lot Number 19KMA947 ; DYNJ04874L , Lot Number 19LMC464 ; DYNJ04874L , Lot Number 20AMC003 ; DYNJ04874L , Lot Number 19BKB479 ; DYNJ04874L , Lot Number 19CKC247 ; DYNJ04874L , Lot Number 19EKB987 ; DYNJ04874L , Lot Number 19GKA360 ; DYNJ04874L , Lot Number 19HKB358 ; DYNJ04879K , Lot Number 19IMB723 ; DYNJ04879K , Lot Number 19JMA492 ; DYNJ04879K , Lot Number 19FKB334 ; DYNJ04879K , Lot Number 19

Distribution pattern

Worldwide distribution.

device · product 75 of 81

Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC LOCAL PACK-LF, Pack Number DYNJ54607A ; 3) LOCAL PACK, Pack Number DYNJ61839B

Z-3055-2024
Recall number
Z-3055-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ34129C , Lot Number 21GBT130 ; DYNJ34129C , Lot Number 21LBL623 ; DYNJ34129C , Lot Number 22ABM033 ; DYNJ34129C , Lot Number 22ABX499 ; DYNJ34129C , Lot Number 19BBD954 ; DYNJ34129C , Lot Number 19DBZ455 ; DYNJ34129C , Lot Number 19EBU077 ; DYNJ34129C , Lot Number 19GBU537 ; DYNJ34129C , Lot Number 22IBG550 ; DYNJ34129C , Lot Number 19JBN034 ; DYNJ34129C , Lot Number 20BBF056 ; DYNJ34129C , Lot Number 23FBG792 ; DYNJ34129C , Lot Number 23GBE376 ; DYNJ34129C , Lot Number 20FBS002 ; DYNJ34129C , Lot Number 23JBR570 ; DYNJ34129C , Lot Number 23JBY629 ; DYNJ34129C , Lot Number 23KBU960 ; DYNJ34129C , Lot Number 23KBW607 ; DYNJ34129C , Lot Number 20KBW597 ; DYNJ34129C , Lot Number 20LBM567 ; DYNJ34129C , Lot Number 21EBA688 ; DYNJ54607A , Lot Number 21HBS933 ; DYNJ54607A , Lot Number 21JBH960 ; DYNJ54607A , Lot Number 21JBZ002 ; DYNJ54607A , Lot Number 21LBJ925 ; DYNJ54607A , Lot Number 19BBP092 ; DYNJ54607A , Lot Number 19CBB568 ; DYNJ54607A , Lot Number 22GBH746 ; DYNJ54607A , Lot Number 22GBZ352 ; DYNJ54607A , Lot Number 19GBT320 ; DYNJ54607A , Lot Number 22IBG226 ; DYNJ54607A , Lot Number 19VBA464 ; DYNJ54607A , Lot Number 19LBN255 ; DYNJ54607A , Lot Number 23EBA098 ; DYNJ54607A , Lot Number 20DBI269 ; DYNJ54607A , Lot Number 20GBW370 ; DYNJ54607A , Lot Number 21ABE502 ; DYNJ54607A , Lot Number 21ABO952 ; DYNJ54607A , Lot Number 21ABT074 ; DYNJ61839B , Lot Number 21JBP698 ; DYNJ61839B , Lot Number 21LBL729 ; DYNJ61839B , Lot Number 22ABU420 ; DYNJ61839B , Lot Number 22EBJ226 ; DYNJ61839B , Lot Number 22HBA748 ; DYNJ61839B , Lot Number 22IBR542 ; DYNJ61839B , Lot Number 19IBN952 ; DYNJ61839B , Lot Number 19LBT615 ; DYNJ61839B , Lot Number 23EBD346 ; DYNJ61839B , Lot Number 23GBE331 ; DYNJ61839B , Lot Number 20DBD020 ; DYNJ61839B , Lot Number 20GBV525 ; DYNJ61839B , Lot Number 20JBC796 ; DYNJ61839B , Lot Number 24ABV143 ; DYNJ61839B , Lot Number 20KBZ290 ; DYNJ61839B , Lot Number 21DBR237 ; DYNJ61839B , Lot Number 21EBP718 ;

Distribution pattern

Worldwide distribution.

device · product 76 of 81

Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015 ; 5) SUTURING KIT, Pack Number MNS15015H; 6) SUTURING SET, Pack Number SUT21770 ; 7) SUTURE SET, Pack Number SUT21810 ; 8) SUTURING SET, Pack Number SUT21810H; 9) SUTURE TRAY , Pack Number SUT21830

Z-3056-2024
Recall number
Z-3056-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

59112, Lot Number 21VBA069 ; DYNDL1984, Lot Number 22IBK601 ; DYNDL1984, Lot Number 22LBA112 ; DYNDL1984, Lot Number 23CBJ757 ; DYNDL1984, Lot Number 23FBI531 ; DYNJ68267A , Lot Number 23GBW001 ; DYNJ68267A , Lot Number 23IBD069 ; MNS15015 , Lot Number 23DLA584 ; MNS15015 , Lot Number 23GLB127 ; MNS15015 , Lot Number 23ILA127 ; MNS15015 , Lot Number 23ILA978 ; MNS15015 , Lot Number 23JLA433 ; MNS15015 , Lot Number 23KLA928 ; MNS15015H, Lot Number 23DLA584 ; MNS15015H, Lot Number 23GLB127 ; MNS15015H, Lot Number 23ILA127 ; MNS15015H, Lot Number 23ILA978 ; MNS15015H, Lot Number 23JLA433 ; MNS15015H, Lot Number 23KLA928 ; SUT21770 , Lot Number 23DBI036 ; SUT21770 , Lot Number 23FBH231 ; SUT21770 , Lot Number 23GBM232 ; SUT21770 , Lot Number 23JBO236 ; SUT21770 , Lot Number 23JBP503 ; SUT21810 , Lot Number 23IBA704 ; SUT21810 , Lot Number 23JMF069 ; SUT21810 , Lot Number 23KME590 ; SUT21810H, Lot Number 23JMF069 ; SUT21810H, Lot Number 23KME590 ; SUT21810H, Lot Number 23IBA704 ; SUT21830 , Lot Number 23KBF032

Distribution pattern

Worldwide distribution.

device · product 77 of 81

Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K

Z-3057-2024
Recall number
Z-3057-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS983505K , Lot Number 23HBC802 ; CDS983505K , Lot Number 23JBQ026 ; CDS983505K , Lot Number 23LBQ345 ; CDS983505K , Lot Number 24ABI223

Distribution pattern

Worldwide distribution.

device · product 78 of 81

Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229

Z-3058-2024
Recall number
Z-3058-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNDH1229 , Lot Number 22FBA002

Distribution pattern

Worldwide distribution.

device · product 79 of 81

Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT , Pack Number DYNDH1641A ; 6) LCPH LAB DRAW KIT , Pack Number DYNDH1641AH; 7) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 8) BLOOD CULTURE, Pack Number DYNDH1921; 9) BLOOD WITHDRAWAL TRAY, Pack Number DYNDV1588F; 10) BLOOD WITHDRAWAL TRAY , Pack Number DYNDV1588G ; 11) PHLEBECTOMY PK, Pack Number DYNJ84749; 12) ARTHROGRAPH TRAY, Pack Number MNS12670A; 13) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915; 14) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915H ; 15) LACERATION TRAY, Pack Number SUT20955

Z-3059-2024
Recall number
Z-3059-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

BP115, Lot Number 21BBG338 ; BP115, Lot Number 21CBE353 ; BP115, Lot Number 21CBJ050 ; DYLAB1044, Lot Number 23GBM782 ; DYNDA1431A, Lot Number 2020012890; DYNDA1683A, Lot Number 2019011790; DYNDA1683A, Lot Number 2019032590; DYNDA1683A, Lot Number 2019042390; DYNDA1683A, Lot Number 2019072390; DYNDA1683A, Lot Number 2019090990; DYNDA1683A, Lot Number 2019102390; DYNDA1683A, Lot Number 2019112290; DYNDA1683A, Lot Number 2020030990; DYNDH1641A , Lot Number 21JBE248 ; DYNDH1641A , Lot Number 21JBY828 ; DYNDH1641AH, Lot Number 21JBE248 ; DYNDH1641AH, Lot Number 21JBY828 ; DYNDH1798, Lot Number 2022112990; DYNDH1921, Lot Number 23KBC196; DYNDV1588F, Lot Number 2019022090; DYNDV1588F, Lot Number 2019041890; DYNDV1588F, Lot Number 2019090390; DYNDV1588F, Lot Number 2020012890; DYNDV1588G , Lot Number 22GBL908 ; DYNDV1588G , Lot Number 22HBN586 ; DYNDV1588G , Lot Number 22JBI927 ; DYNDV1588G , Lot Number 22LBK218 ; DYNDV1588G , Lot Number 23ABJ940 ; DYNDV1588G , Lot Number 23EBB512 ; DYNDV1588G , Lot Number 23EBU397 ; DYNDV1588G , Lot Number 23IBU991 ; DYNDV1588G , Lot Number 23KBS797 ; DYNJ84749, Lot Number 23HBE651 ; DYNJ84749, Lot Number 23JBD780 ; MNS12670A, Lot Number 2022112990; MNS8915, Lot Number 21GBS360 ; MNS8915, Lot Number 21HBU417 ; MNS8915, Lot Number 21JBI844 ; MNS8915, Lot Number 21JBY844 ; MNS8915, Lot Number 21LBO003 ; MNS8915, Lot Number 21LBS501 ; MNS8915, Lot Number 22CBY070 ; MNS8915, Lot Number 22HBA169 ; MNS8915, Lot Number 22HBT299 ; MNS8915, Lot Number 22IBR400 ; MNS8915, Lot Number 22KBV233 ; MNS8915, Lot Number 23ABF223 ; MNS8915, Lot Number 23CBT546 ; MNS8915, Lot Number 23DBA141 ; MNS8915, Lot Number 23EBF405 ; MNS8915, Lot Number 23FBF145 ; MNS8915, Lot Number 23GBH740 ; MNS8915, Lot Number 23IBL050 ; MNS8915, Lot Number 23JBK017 ; MNS8915, Lot Number 23LBE535 ; MNS8915, Lot Number 24ABQ710 ; MNS8915H , Lot Number 21GBS360 ; MNS8915H , Lot Number 21HBU417 ; MNS8915H , Lot Number 21JBI844 ; MNS8915H , Lot Number 21JBY844 ; MNS8915H , Lot Number 21LBO003 ; MNS8915H , Lot Number 21LBS501 ; MNS8915H , Lot Number 22CBY070 ; MNS8915H , Lot Number 22HBA169 ; MNS8915H , Lot Number 22HBT299 ; MNS8915H , Lot Number 22IBR400 ; MNS8915H , Lot Number 22KBV233 ; MNS8915H , Lot Number 23ABF223 ; MNS8915H , Lot Number 23CBT546 ; MNS8915H , Lot Number 23DBA141 ; MNS8915H , Lot Number 23EBF405 ; MNS8915H , Lot Number 23FBF145 ; MNS8915H , Lot Number 23GBH740 ; MNS8915H , Lot Number 23IBL050 ; MNS8915H , Lot Number 23JBK017 ; MNS8915H , Lot Number 23LBE535 ; MNS8915H , Lot Number 24ABQ710 ; SUT20955, Lot Number 2020012890

Distribution pattern

Worldwide distribution.

device · product 80 of 81

Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F

Z-3060-2024
Recall number
Z-3060-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

CDS983874F , Lot Number 19JDA152 ; CDS983874F , Lot Number 19KDC441 ; CDS983874F , Lot Number 20ADB656 ; CDS983874F , Lot Number 20BDC710 ; CDS983874F , Lot Number 20EDA493 ; CDS983874F , Lot Number 20FDB761 ; CDS983874F , Lot Number 20JDC993 ; CDS983874F , Lot Number 21ADB720 ; CDS983874F , Lot Number 21DDA797 ; CDS983874F , Lot Number 21FDB765 ; CDS983874F , Lot Number 21HDA924 ; CDS983874F , Lot Number 21KDA957 ; CDS983874F , Lot Number 22BDA224 ; CDS983874F , Lot Number 22DDB013 ; CDS983874F , Lot Number 22GDA535 ; CDS983874F , Lot Number 22HDC091 ; CDS983874F , Lot Number 22JDA459 ; CDS983874F , Lot Number 23ADB076 ; CDS983874F , Lot Number 23DDA408 ; CDS983874F , Lot Number 23FDB732 ; CDS983874F , Lot Number 23IDA600 ; CDS983874F , Lot Number 23LDA901 ; CDS983874F , Lot Number 24CDA648 ; CDS984080F, Lot Number 23FBF618; CDS984080F, Lot Number 23EBN989; CDS984080F, Lot Number 23BBR987; CDS984080F, Lot Number 23ABH436; CDS984080F, Lot Number 23ABF537; CDS984080F, Lot Number 22IBR063; CDS984080F, Lot Number 22HBJ841

Distribution pattern

Worldwide distribution.

device · product 81 of 81

Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN PACK , Pack Number DYNJ69770A ; 7) SMALL BURN PACK , Pack Number DYNJ69797; 8) SMALL BURN PACK , Pack Number DYNJ69797A ; 9) BURN PACK-LF, Pack Number DYNJ82534; 10) BURN PACK-LF, Pack Number DYNJ82534H ; 11) BASIC BURN PACK , Pack Number DYNJ82729; 12) BURN PACK , Pack Number DYNJ83254; 13) BURN PACK , Pack Number DYNJ84744

Z-3061-2024
Recall number
Z-3061-2024
Initiated
April 08, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

DYNJ0781678S , Lot Number 19LMC634 ; DYNJ0781678S , Lot Number 20AMD173 ; DYNJ0781678S , Lot Number 20CMC665 ; DYNJ0781678S , Lot Number 20EMB965 ; DYNJ0781678S , Lot Number 20GMC952 ; DYNJ0781678S , Lot Number 20JMD288 ; DYNJ0781678S , Lot Number 21CMB052 ; DYNJ0781678S , Lot Number 21CME303 ; DYNJ0781678S , Lot Number 21GME666 ; DYNJ0781678S , Lot Number 21IMD184 ; DYNJ0781678S , Lot Number 21KMG512 ; DYNJ0781678S , Lot Number 22AMF686 ; DYNJ0781678S , Lot Number 22BMA737 ; DYNJ0781678S , Lot Number 22DMI132 ; DYNJ0781678S , Lot Number 22EMB432 ; DYNJ0781678S , Lot Number 22EMI061 ; DYNJ0781678S , Lot Number 22GMB212 ; DYNJ0781678S , Lot Number 22IMC056 ; DYNJ0781678S , Lot Number 22KMB510 ; DYNJ0781678S , Lot Number 23AMD737 ; DYNJ0781678S , Lot Number 23BMC741 ; DYNJ0781678S , Lot Number 23CMG452 ; DYNJ0781678S , Lot Number 23EMJ106 ; DYNJ0781678S , Lot Number 23GMC393 ; DYNJ0781678S , Lot Number 23HMB925 ; DYNJ0781678S , Lot Number 23HMI837 ; DYNJ0781678S , Lot Number 23JME009 ; DYNJ0781678S , Lot Number 23LMG524 ; DYNJ0976092P , Lot Number 22KBM419 ; DYNJ0976092P , Lot Number 23ABI393 ; DYNJ0976092P , Lot Number 23ABU953 ; DYNJ0976092P , Lot Number 23CBO918 ; DYNJ0976092P , Lot Number 23FBK157 ; DYNJ0976092P , Lot Number 23FBO968 ; DYNJ0976092P , Lot Number 23HBP114 ; DYNJ0976092P , Lot Number 23JBJ268 ; DYNJ0976092P , Lot Number 23JBX458 ; DYNJ0976092P , Lot Number 23LBO309 ; DYNJ42829B , Lot Number 21VBB243 ; DYNJ42829B , Lot Number 21KBX160 ; DYNJ42829B , Lot Number 21LBJ187 ; DYNJ42829B , Lot Number 22CBG053 ; DYNJ42829B , Lot Number 22DBM155 ; DYNJ42829B , Lot Number 22EBF406 ; DYNJ42829B , Lot Number 22EBQ033 ; DYNJ42829B , Lot Number 22HBL593 ; DYNJ42829B , Lot Number 22IBI084 ; DYNJ42829B , Lot Number 22JBT931 ; DYNJ54386C , Lot Number 21HMA145 ; DYNJ54386C , Lot Number 21HMF539 ; DYNJ54386C , Lot Number 22CMC496 ; DYNJ54386C , Lot Number 22EMA072 ; DYNJ54386C , Lot Number 22GMC085 ; DYNJ54386C , Lot Number 22HMC997 ; DYNJ54386C , Lot Number 23BMD997 ; DYNJ54386C , Lot Number 23BME291 ; DYNJ54386C , Lot Number 23BME299 ; DYNJ54386C , Lot Number 23HMD808 ; DYNJ54386C , Lot Number 23JME585 ; DYNJ54386C , Lot Number 23KMJ519 ; DYNJ54386C , Lot Number 24AMA687 ; DYNJ69770, Lot Number 21JBZ854 ; DYNJ69770, Lot Number 21KBG572 ; DYNJ69770, Lot Number 22FBF083 ; DYNJ69770, Lot Number 22GBS150 ; DYNJ69770, Lot Number 22IBI498 ; DYNJ69770, Lot Number 22IBI500 ; DYNJ69770, Lot Number 23ABF148 ; DYNJ69770A , Lot Number 23BBM922 ; DYNJ69770A , Lot Number 23BBN136 ; DYNJ69770A , Lot Number 23DBB253 ; DYNJ69770A , Lot Number 23GBE013 ; DYNJ69770A , Lot Number 23HBP947 ; DYNJ69770A , Lot Number 23IBD392 ; DYNJ69770A , Lot Number 23LBH034 ; DYNJ69770A , Lot Number 24ABD199 ; DYNJ69797, Lot Number 21VBB057 ; DYNJ69797, Lot Number 22FBU011 ; DYNJ69797, Lot Number 22IBL650 ; DYNJ69797, Lot Number 22JBS235 ; DYNJ69797, Lot Number 22LBN180 ; DYNJ69797A , Lot Number 23ABR780 ; DYNJ69797A , Lot Number 23CBC665 ; DYNJ69797A , Lot Number 23DBA361 ; DYNJ69797A , Lot Number 23DBP443 ; DYNJ69797A , Lot Number 23FBD706 ; DYNJ69797A , Lot Number 23GBH073 ; DYNJ69797A , Lot Number 23IBI641 ; DYNJ69797A , Lot Number 23JBM947 ; DYNJ82534, Lot Number 22HBI219 ; DYNJ82534, Lot Number 23ABI062 ; DYNJ82534, Lot Number 23ABI245 ; DYNJ82534, Lot Number 23ABT142 ; DYNJ82534, Lot Number 23CBA657 ; DYNJ82534, Lot Number 23FBA414 ; DYNJ82534, Lot Number 23GBB353 ; DYNJ82534, Lot Number 23HBN063 ; DYNJ82534, Lot Number 23IBO398 ; DYNJ82534, Lot Number 23KBP925 ; DYNJ82534H , Lot Number 22HBI219 ; DYNJ82534H , Lot Number 23ABI062 ; DYNJ82534H , Lot Number 23ABI245 ; DYNJ82534H , Lot Number 23ABT142 ; DYNJ82534H , Lot Number 23CBA657 ; DYNJ82534H , Lot Number 23FBA414 ; DYNJ82534H , Lot Number 23GBB353 ; DYNJ82534H , Lot Number 23HBN063 ; DYNJ82534H , Lot Number 23IBO398 ; DYNJ82534H , Lot Number 23KBP925 ; DYNJ82729, Lot Number 22KMF062 ; DYNJ82729, Lot Number 23CMF962 ; DYNJ82729, Lot Number 23DMG875 ; DYNJ82729, Lot Number 23EME128 ; DYNJ82729, Lot Number 23FMB967 ; DYNJ82729, Lot Number 23GMD583 ; DYNJ82729, Lot Number 23IMG264 ; DYNJ82729, Lot Number 23LMF995 ; DYNJ82729, Lot Number 24AMC492 ; DYNJ83254, Lot Number 22LBO275 ; DYNJ83254, Lot Number 23CBM480 ; DYNJ84744, Lot Number 23GMF409

Distribution pattern

Worldwide distribution.

Field note

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