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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92875

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

Open FDA event record

Event summary

Timeline bucket
August 16, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cardinal Health 200, LLC

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

10 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 10

Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.

Z-0083-2024
Recall number
Z-0083-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

(1) Cat. SBAHFPTAS2 - Lot #900813, exp. 1/1/2025, UDI-DI 10195594810351; and (2) Cat. SNE37ANMOF - Lot #32724, exp. 4/1/2025, UDI-DI 10195594576080.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 2 of 10

Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.

Z-0084-2024
Recall number
Z-0084-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

(1) Cat. PC71EXOU7 - Lot #916915, Exp. 5/1/2024, UDI-DI 10195594873332; (2) Cat. PVOCMVBLC - Lot #922978, Exp. 10/1/2024; and Lot #922978, Exp. 7/1/2024, UDI-DI 10195594763183; (3) Cat. PVRMMVAOH7 - Lot #923996, Exp. 1/1/2024, UDI-DI 10195594892777; (4) Cat. PV30VPUHA - Lot #898892, Exp. 2/1/2024, UDI-DI 10195594485894; (5) Cat. SANOCCPDM2 - Lot #920122, Exp. 6/1/2025, UDI-DI 10195594882273; (6) Cat. SAN1FPMULM - Lot #929016, Exp. 6/1/2024, UDI-DI 10195594712938; (7) Cat. SAN11OADMM - Lot #985859, Exp. 11/1/2025, UDI-DI 10195594553562; (8) Cat. SAN13DILCO - Lot #936019, Exp. 8/1/2024, UDI-DI 10888439914443; (9) Cat. SAN13DILC6 - Lot #22275, Exp. 5/1/2024, UDI-DI 10197106209561; (10) Cat. SAN21AO62F - Lot #901120, Exp. 8/1/2024, UDI-DI 10888439936100; (11) Cat. SAN21APJCD - Lot #922242, Exp. 8/1/2024, UDI-DI 10195594574918; (12) Cat. SAN21IP62I - Lot #917437, Exp. 6/1/2024, UDI-DI 10888439936018; (13) Cat. SAN23CMCW5 - Lot #919954, Exp. 7/1/2024, UDI-DI 10195594885915; (14) Cat. SAN29PCCCL - Lot #999073, Exp. 6/1/2027, UDI-DI 10888439917291; (15) Cat. SAN3BPDKOC - Lot #942109, Exp. 1/1/2024, UDI-DI 10888439964530; (16) Cat. SAN3BPDK12 - Lot #914221, Exp. 1/1/2024, UDI-DI 10195594863579; (17) Cat. SAN30ANTHD - Lot #16600, Exp. 7/1/2025, UDI-DI 10888439973334; (18) Cat. SAN30PPVGA - Lot #922151, Exp. 5/1/2025, UDI-DI 10195594119409; (19) Cat. SAN32IPJWA - Lot #986373, Exp. 4/1/2024, UDI-DI 10888439903881; (20) Cat. SAN33HCSFI - Lot #918244, Exp. 10/1/2024, UDI-DI 10195594302375; (21) Cat. SAN33PMDWI - Lot #973944, Exp. 9/1/2027, UDI-DI 10888439900880; (22) Cat. SAN53OPVMG - Lot #916151, Exp. 7/1/2024, UDI-DI 10195594764401; (23) Cat. SAN55PMMMK - Lot #940130, Exp. 4/1/2024, UDI-DI 10195594395247; (24) Cat. SAN55PMMM9 - Lot #920265, Exp. 9/1/2024, UDI-DI 10195594892173; (25) Cat. SAN57PM80G - Lot #918511, Exp. 4/1/2025, UDI-DI 10195594714451; (26) Cat. SAN69ENKBK - Lot #940361, Exp. 8/1/2025, UDI-DI 10888439549881; (27) Cat. SCVOCVACMI - Lot #924218, Exp. 12/1/2024, UDI-DI 10195594696924; (28) Cat. SCVW1VAHFL - Lot #945247, Exp. 8/1/2025, UDI-DI 10888439912173; (29) Cat. SCV11AVDMF - Lot #17725, Exp. 6/1/2025, UDI-DI 10197106013328;s (30) Cat. SCV11AVD13 - Lot #59718, Exp. 12/1/2025, UDI-DI 10197106306543; (31) Cat. SCV11TBTJH - Lot #940443, Exp. 2/1/2024, UDI-DI 10888439899078; (32) Cat. SCV30EVTHE - Lot #38772, Exp. 1/1/2025, UDI-DI 10888439973235; (33) Cat. SCV30PMRGA - Lot #9591, Exp. 10/1/2027, UDI-DI 10887488561110; and (34) Cat. SOT30PCHSC - Lot #54914, Exp. 3/1/2024, UDI-DI 10195594626402.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 3 of 10

Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

Z-0085-2024
Recall number
Z-0085-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

Lot #967679, Exp. 9/1/2024, UDI-DI 10195594543259.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 4 of 10

Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.

Z-0086-2024
Recall number
Z-0086-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

(1) Cat. PG33BTO21 - Lot #914590, Exp. 6/1/2024, UDI-DI 10195594884130; (2) Cat. PG33BTO22 - Lot #928313, Exp. 2/1/2024, UDI-DI 10197106010419; (3) Cat. PG33SROUB - Lot #81580, Exp. 12/1/2024, UDI-DI 10197106186930; (4) Cat. PUMHCCESP - Lot #4316, Exp. 2/1/2025 and 9/1/2025, UDI-DI 10195594542153; (5) Cat. SBA18GLEFF - Lot #895495, Exp. 6/1/2025 and Exp. 7/1/2025, UDI-DI 10888439910209; (6) Cat. SOTCGPPMEA - Lot #984246, Exp. 7/1/2025 and Exp. 5/1/2024, UDI-DI 10888439847475; (7) Cat. SOT18CYEFC - Lot #928044, Exp. 4/1/2027, UDI-DI 10888439910216; (8) Cat. SOT29GUHCD - Lot #986052, Exp. 6/1/2027, UDI-DI 10195594963811; (9) Cat. SOT30PENBB - Lot #987163, Exp. 8/1/2025, UDI-DI 10888439948707; (10) Cat. SOT33PNO13 - Lot #920956, Exp. 8/1/2024, UDI-DI 10195594887452; (11) Cat. SOT33PNO15 - Lot #966904, Exp. 6/1/2024, UDI-DI 10197106087619; (12) Cat. SOT51CPKOA - Lot #916606, Exp. 11/1/2023, UDI-DI 10887488777795; (13) Cat. SOT51CPK10 - Lot #997330, Exp. 2/1/2024, UDI-DI 10197106161418; (14) Cat. SOT69PCKSA - Lot #997386, Exp. 3/1/2024, UDI-DI 10888439898071; (15) Cat. SOT7APNLVB - Lot #930337, Exp. 5/1/2024, UDI-DI 10888439925708; and (16) Cat. SOT73CPKSB - Lot #923138 Exp. 1/1/2025, UDI-DI 10888439906561.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 5 of 10

Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile; (6) Presource Robotic Module Pack, Cat. SBAOCRBEN8, Englewood Hospital and Medical, Sterile; (7) Presource FMC Liver Resection Pack, Cat. SBA30MJCHH, AHS Calgary Zone, Sterile; (8) Presource ALIF Pack, Cat. SBA41ALFME, USPI Baylor Med Ctr at Fri, Sterile; (9) Presource ACDF Pack, Cat. SBA44ACWBF, Webster Surgical Specialty Hos, Sterile; (10) Presource Lap Chole Pack, Cat. SBA54LADNA, USPI Paso Del Norte Srgry Ctr, Sterile; (11) Presource Lap Chole Pack, Cat. SBA54LADN3, USPI Paso Del Nrte Srgry Ctr, Sterile; (12) Presource Salle Hybride Ensemble, Cat. SCV30THLHA, Inst Univ Cardio ET Pneumo, Sterile; (13) Presource AMB Perc Pack, Cat. SMA57PR00B, Oregon Health Science Universi, Sterile; (14) Presource KP Vacaville Lami Pack, Cat. SNE69LPKVB, KP Vacaville, Sterile; (15) Presource Kyphoplasty Pack, Cat. SOP26KPMHB, Moffitt Cancer Center, Sterile; (16) Presource Percutaneous Nephro Pack, Cat. SOT30PELCA, Lakeridge Health Corporation, Sterile; and (17) Presource PBDS Infection Control Turnover Kit, Cat. ORC511687B, Sequoia Surgery Center LLC, Sterile.

Z-0087-2024
Recall number
Z-0087-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

(1) Cat. PGMHSUESR - Lot #54698, Exp. 2/1/2025 and Exp. 6/1/2024, UDI-DI 10195594542757; (2) Cat. PGVGLBP20 - Lot #921831, Exp. 4/1/2024, UDI-DI 10195594892210; (3) Cat. PG63CCC31 - Lot #940845, Exp. 9/1/2023, UDI-DI 10197106032978; (4) Cat. PG63CCC34 - Lot #46817, Exp. 2/1/2024, UDI-DI 10197106279342; (5) Cat. SBAOCRBENF - Lot #985693, Exp. 7/1/2024, UDI-DI 10195594735999; (6) Cat. SBAOCRBEN8 - Lot #920306, Exp. 6/1/2024, UDI-DI 10195594882334; (7) Cat. SBA30MJCHH - Lot #937398, Exp. 4/1/2025, UDI-DI 10195594759766; (8) Cat. SBA41ALFME - Lot #981380, Exp. 12/1/2024, UDI-DI 10887488946573; (9) Cat. SBA44ACWBF - Lot #986205, Exp. 10/1/2024, UDI-DI 10888439902877; (10) Cat. SBA54LADNA - Lot #998437, Exp. 3/1/2026, UDI-DI 10888439912135; (11) Cat. SBA54LADN3 - Lot #921655, Exp. 2/1/2024, UDI-DI 10195594891275; (12) Cat. SCV30THLHA - Lot #919439, Exp. 1/1/2024, UDI-DI 10195594133559; (13) Cat. SMA57PR00B - Lot #922735, Exp. 3/1/2025, UDI-DI 10195594514259; (14) Cat. SNE69LPKVB - Lot #953055, Exp. 7/1/2024, UDI-DI 10195594578916; (15) Cat. SOP26KPMHB - Lot #17915, Exp. 9/1/2024, Exp. 8/1/2024, and Exp. 1/1/2025, UDI-DI 10888439903133; (16) Cat. SOT30PELCA - Lot #919471, UDI-DI 10195594513665; and (17) Cat. ORC511687B - Lot #18365, UDI-DI 10887488892696.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 6 of 10

Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, Sterile.

Z-0088-2024
Recall number
Z-0088-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

(1) Cat. SANV1PIFSB - Lot #67711, Exp. 3/1/2026, UDI-DI 10195594532048; and (2) Cat. SAN12BHGT1 - Lot #13526, Exp. 3/1/2024, UDI-DI 10197106202715.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 7 of 10

Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile; (6) Presource PBDS Cat. PN40CD806, Kit, Pedi C D, RWJ, Sterile; (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile; (8) Presource PBDS Cat. PN73APVD7, Kit, Neuro Spine Module, Sterile; (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile; (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile; (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile; (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile; (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile; (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile; (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile; (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile; (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile; (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile; (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile; (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile; (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile; (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile; (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile; (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile; (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile; (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile; (27) Presource Complex Spine Pack, Cat. SNE12NS388, Sterile; (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile; (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile; (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile; (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile; (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile; (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile; (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile; (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile; (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile; (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile; (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile; (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile; (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile; (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile; (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile; (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile; (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile; (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile; (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile.

Z-0089-2024
Recall number
Z-0089-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

(1) Cat. PNVMNIB21 - Lot #920364, Exp. 6/1/2024, UDI-DI 10195594891879; (2) Cat. PN08LAG13 - Lot #920368, Exp. 6/1/2024, UDI-DI 10195594886516; (3) Cat. PN08LAG17 - Lot #987136, Exp. 11/1/2024, UDI-DI 10197106132944; (4) Cat. PN11SFS40 - Lot #917897, Exp. 6/1/2024, UDI-DI 10195594875060; (5) Cat. PN33DBOU3 - Lot #918902, Exp. 8/1/2023, UDI-DI 10195594878627; (6) Cat. PN40CD806 - Lot #17765, Exp. 5/1/2024, UDI-DI 10197106202968; (7) Cat. PN73APVDE - Lot #936774, Exp. 9/1/2023, UDI-DI 10195594742065; (8) Cat. PN73APVD7 - Lot #931972, Exp. 9/1/2023, UDI-DI 10197106016787; (9) Cat. POHFSPMHC - Lot #929330, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903096; (10) Cat. SAN73PPTAC - Lot #964384, Exp. 6/1/2025, UDI-DI 10888439008166; (11) Cat. SNECGLPCOB - Lot #917630, Exp. 6/1/2024, UDI-DI 10195594560942; (12) Cat. SNECGNSEBF - Lot #940134, Exp. 8/1/2024, UDI-DI 10197106002537; (13) Cat. SNECGNSEB4 - Lot #990736, Exp. 11/1/2024, UDI-DI 10197106143315; (14) Cat. SNECGSPAUH - Lot #923838, Exp. 4/1/2024, UDI-DI 10195594271480; (15) Cat. SNECGSPSGG - Lot #17548, Exp. 11/1/2024 and Exp. 5/1/2024, UDI-DI 10197106131572; (16) Cat. SNEDKCSWDB - Lot #977629, Exp. 10/1/2024, UDI-DI 10197106029800; (17) Cat. SNEDKLLFLF - Lot #917621, Exp. 5/1/2024 and Exp. 11/1/2024, UDI-DI 10195594948528; (18) Cat. SNEHDNSRVJ - Lot #18167, Exp. 5/1/2024, UDI-DI 10888439902938; (19) Cat. SNEOCLPLSC - Lot #16886, Exp. 5/1/2025, UDI-DI 10195594963200; (20) Cat. SNEOCNPNBC - Lot #922662, Exp. 1/1/2024, UDI-DI 10887488974897; (21) Cat. SNE11LMENX - Lot #918521, Exp. 6/1/2024, UDI-DI 10195594736026; (22) Cat. SNE11SPDML - Lot #923218, Exp. 9/1/2023, UDI-DI 10195594433482; (23) Cat. SNE12ACGTY - Lot #16589, Exp. 6/1/2024, UDI-DI 10888439665093; (24) Cat. SNE12LM33J - Lot #923782, Exp. 4/1/2024, UDI-DI 10888439665116; (25) Cat. SNE12LM348 - Lot #992523, Exp. 7/1/2024, UDI-DI 10197106150399; (26) Cat. SNE12LM349 - Lot #997471, Exp. 12/1/2024, UDI-DI 10197106162149; (27) Cat. SNE12NS388 - Lot #987470, Exp. 12/1/2024, UDI-DI 10197106134146; (28) Cat. SNE12SPHMS - Lot #923360, Exp. 7/1/2024, UDI-DI 10195594660895; (29) Cat. SNE23SPGTH - Lot #999249, Exp. 1/1/2025, UDI-DI 10197106078150; (30) Cat. SNE33NROUE - Lot #919347, Exp. 12/1/2024, UDI-DI 10195594792558; (31) Cat. SNE33SPO11 - Lot #941910, Exp. 9/1/2024, UDI-DI 10197106034149; (32) Cat. SNE35NABLD - Lot #922223, Exp. 6/1/2025, UDI-DI 10888439939651; (33) Cat. SNE40SPPCH - Lot #48287, Exp. 12/1/2023 and Exp. 7/1/2024, UDI-DI 10195594455033; (34) Cat. SNE41NBCSE - Lot #990152, Exp. 10/1/2024, UDI-DI 10888439916355; (35) Cat. SNE41NBCS9 - Lot #919989, Exp. 7/1/2024, UDI-DI 10195594880538; (36) Cat. SNE43LNOG6 - Lot #34812, Exp. 5/1/2024, UDI-DI 10197106250495; (37) Cat. SNE51NBMRL - Lot #932527, Exp. 8/1/2024, UDI-DI 10888439575125; (38) Cat. SNE53NEFCH - Lot #24957, Exp. 5/1/2024 and Exp. 8/1/2024, UDI-DI 10195594368593; (39) Cat. SNE53SFVMF - Lot #986877, Exp. 2/1/2024, UDI-DI 10195594764562; (40) Cat. SNE57NP00A - Lot #930583, Exp. 7/1/2024, UDI-DI 10195594512552; (41) Cat. SNE57SPKPX - Lot #929434, Exp. 10/1/2024 and Exp. 7/1/2024, UDI-DI 10195594075507; (42) Cat. SNE69SPFRL - Lot #931449 Exp. 7/1/2024, UDI-DI 10195594447519; (43) Cat. SNE73NSCTJ - Lot #986478, Exp. 11/1/2024, UDI-DI 10195594678562; (44) Cat. SNE73SPKFL - Lot #950758, Exp. 8/1/2024, UDI-DI 10888439662986; (45) Cat. SNE73SPTAC - Lot #900047, Exp. 5/1/2024 and Exp. 6/1/2024, UDI-DI 10888439136975; (46) Cat. SNE81ACNMN - Lot #17214, Exp. 4/1/2025, and Lot #D221752, Exp. 5/1/2024, UDI-DI 10195594733018; and (47) Cat. SNE81ULNMO - Lot #931699, Exp. 5/1/2024, UDI-DI 10888439934113.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 8 of 10

Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.

Z-0090-2024
Recall number
Z-0090-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

Lot #81461, Exp. 6/1/2024 and Exp. 9/1/2024, UDI-DI 10195594542795.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 9 of 10

Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS Cat. PO08LXG21, Kit, Extremity, Grant, Sterile; (9) Presource PBDS Cat. PO11HRFH6, Kit, Anterior Hip, Sterile; (10) Presource PBDS Cat. PO11OTASS8, Kit, Trauma Hip A and B, Sterile; (11) Presource PBDS Cat. PO11OTSSP, Kit, Trauma Knee A and B, Sterile; (12) Presource PBDS Cat. PO11THAS13, Kit, Anterior Hip, Sterile; (13) Presource PBDS Cat. PO12AHSUQ, Kit, Anterior Hip, Sterile; (14) Presource PBDS Cat. PO12AHSU7, Kit, Anterior Hip, Sterile; (15) Presource PBDS, Cat. PO18AHEFG, Kit, Anterior Hip, Sterile; (16) Presource PBDS Cat. PO3LHPLM2, Kit, Hip Pinning, Sterile; (17) Presource PBDS Cat. PO3LHPLM3, Kit, Hip Pinning, Sterile; (18) Presource PBDS Cat. PO33AHCRA, Kit, Anterior Hip, Sterile; (19) Presource PBDS Cat. PO56MLGRA, Kit, MC Lower Extremity, Sterile; (20) Presource Spine Pack, Cat. SNECGSPAHB,Sterile; (21) Presource Spine Pack, Cat. SNECGSPAH4, Sterile; (22) Presource Ortho Laminectomy Pack, Cat. SNE12OL89A, Sterile; (23) Presource ACD Pack, Cat. SNE33ACCRD, Sterile; (24) Presource Anterior Fusion Pack, Cat. SNE33AFC18, Sterile; (25) Presource Lumbar Disk Pack, Cat. SNE33LMCAB, Sterile; (26) Presource SDMC Ortho Spine Accessory Pk, Cat. SNE73SAKSD, Sterile; (27) Presource Hip Arthroscopy Pack, Cat. SOPCNHAMSD, Sterile; (28) Presource Anterior Approach Total Hip Pk, Cat. SOPDKAHC12, Sterile; (29) Presource Physician Partner of America, Cat. SOPHFLSHAC, Sterile; (30) Presource MH Hip With Curtain Std Pack, Cat. SOPMHHCM10, Sterile; (31) Presource Back Pack, Cat. SOPOCBPLSD, Sterile; (32) Presource HFHS Ortho Spine Pack, Cat. SOPW1OSHFM, Sterile; (33) Presource PED Extremity Pack, Cat. SOP11PER12, Sterile; (34) Presource Hip Arthroscopy Pack, Cat. SOP12HAGTC, Sterile; (35) Presource OPSC Hip Arthroscopy Pack, Cat. SOP12HAUVE, Sterile; (36) Presource Major Ortho, Cat. SOP12MJHM6, Sterile; (37) Presource Pedi Ortho Spine W Basin Pack, Cat. SOP22PSMRE, Sterile; (38) Presource Lower Extremity Pack 302095, Cat. SOP3LLESGK, Sterile; (39) Presource ORIF Wrist Sturgeon Pack, Cat. SOP30ACSCG, Sterile; (40) Presource Ensemble Pied Cheville 3, Cat. SOP30AKJTF, Sterile; (41) Presource Fracture Pack, Cat. SOP30FRUHE, Sterile; (42) Presource Anterior Total Hip Pack, Cat. SOP30HALHB, Sterile; (43) Presource Hip Pack, Cat. SOP30HPWME, Sterile; (44) Presource Hip Scope Pack, Cat. SOP30HSCHE, Sterile; (45) Presource Ortho Split Pack, Cat. SOP30OSVI8, Sterile; (46) Presource Pack Trauma Uppr Extrmty Civic, Cat. SOP30UPOHD, Sterile; (47) Presource Anterior Hip Pack, Cat. SOP32AHGMH, Sterile; (48) Presource Anterior Tha Pack, Cat. SOP33ANOOI, Sterile; (49), Presource CPT Ortho Custom UH Pack, Cat. SOP33OROUJ, Sterile; (50) Presource CPT Ortho Custom UH Pack, Cat. SOP33OROU5, Sterile; (51) Presource Anterior Hip Pk, Cat. SOP35AHAMG, Sterile; (52) Presource Hip Pack, Cat. SOP41HISP6, Sterile; (53) Presource Spine Tray, Cat. SOP44STHPC, Sterile; (54) Presource Anterior Hip Pack, Cat. SOP5BAHHEE, Sterile; (55) Presource Essentia Anterior Hip Surgi Pk, Cat. SOP5BHSEHD, Sterile; (56) Presource CPT Ortho Custom James Pk, Cat. SOP5CCJOUH, Sterile; (57) Presource Back Part 1, Cat. SOP51BAKOF, Sterile; (58) Presource Back Part 1, Cat. SOP51BAKO9, Sterile; (59) Presource Pack Total Hip Anter Surg WMC, Cat. SOP53APKP4, Sterile; (60) Presource West Hip Anterior Total Pack, Cat. SOP56HAMT8, Sterile; (61) Presource Anterior Hip Pack, Cat. SOP57AHSH5, Sterile; (62) Presource Total Hip Pack, Cat. SOP6VTHPOA, Sterile; (63) Presource ASU Hip Arthroscopy Pack, Cat. S

Z-0091-2024
Recall number
Z-0091-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

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 · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

(1) Cat. PN33BPCR2 - Lot #986971, Exp. 9/1/2024, UDI-DI 10197106132319; (2) Cat. POCGANA11 - Lot #936749, Exp. 8/1/2024, UDI-DI 10197106027257; (3) Cat. PODKHAKAB - Lot #18022, Exp. 5/1/2024, UDI-DI 10888439441819; (4) Cat. POMHKAESV - Lot #967651, Exp. 12/1/2023, UDI-DI 10195594543341; (5) Cat. POMHLEE11 - Lot #39223, Exp. 8/1/2024, UDI-DI 10197106255087; (6) Cat. POMVTHANLE - Lot #926669, Exp. 9/1/2023, UDI-DI 10195594471781; (7) Cat. POVMPAB11 - Lot #951430, Exp. 8/1/2024, UDI-DI 50197106054701; (8) Cat. PO08LXG21 - Lot #941775, Exp. 12/1/2024, UDI-DI 10197106032404; (9) Cat. PO11HRFH6 - Lot #921333, Exp. 5/1/2024, UDI-DI 10195594894191; (10) Cat. PO11OTASS8 - Lot #920211, Exp. 2/1/2024, UDI-DI 10195594888121; (11) Cat. PO11OTSSP - Lot #57290, Exp. 4/1/2024, UDI-DI 10197106108611; (12) Cat. PO11THAS13 - Lot #966763, Exp. 8/1/2024, UDI-DI 10197106087190; (13) Cat. PO12AHSUQ - Lot #930429, Exp. 1/1/2024, UDI-DI 10195594397760; (14) Cat. PO12AHSU7 - Lot #17680, Exp. 10/1/2024, UDI-DI 10197106201329; (15) Cat. PO18AHEFG - Lot #940003, Exp. 8/1/2024, UDI-DI 10888439910193; (16) Cat. PO3LHPLM2 - Lot #905668, Exp. 6/1/2025, UDI-DI 10195594828790; (17) Cat. PO3LHPLM3 - Lot #925611, Exp. 7/1/2025, UDI-DI 10197106000298; (18) Cat. PO33AHCRA - Lot #998611, Exp. 1/1/2025, UDI-DI 10195594899264; (19) Cat. PO56MLGRA - Lot #4327, Exp. 7/1/2025, UDI-DI 10197106115008; (20) Cat. SNECGSPAHB - Lot #986454, Exp. 9/1/2024, UDI-DI 10195594020798; (21) Cat. SNECGSPAH4 - Lot #40840, Exp. 9/1/2024, UDI-DI 10197106266328; (22) Cat. SNE12OL89A - Lot #18306, Exp. 12/1/2023 and 5/1/2024, UDI-DI 10195594527723; (23) Cat. SNE33ACCRD - Lot #931311, Exp. 6/1/2024, UDI-DI 10195594895839; (24) Cat. SNE33AFC18 - Lot #941894, Exp. 8/1/2024, UDI-DI 10197106033807; (25) Cat. SNE33LMCAB - Lot #922696, Exp. 8/1/2024 and Exp. 5/1/2024, UDI-DI 10195594472559; (26) Cat. SNE73SAKSD - Lot #920769, Exp. 8/1/2024, UDI-DI 10888439615173; (27) Cat. SOPCNHAMSD - Lot #969039, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903140; (28) Cat. SOPDKAHC12 - Lot #997357, Exp. 9/1/2024, UDI-DI 10197106163337; (29) Cat. SOPHFLSHAC - Lot #998464, Exp. 4/1/2027, UDI-DI 10888439912098; (30) Cat. SOPMHHCM10 - Lot #996397, Exp. 12/1/20025, UDI-DI 10197106163634; (31) Cat. SOPOCBPLSD - Lot #893040, Exp. 4/1/2024, UDI-DI 10888439909210; (32) Cat. SOPW1OSHFM - Lot #931594, Exp. 7/1/2024, UDI-DI 10888439936759; (33) Cat. SOP11PER12 - Lot #920426, Exp. 8/1/2023, UDI-DI 10195594880781; (34) Cat. SOP12HAGTC - Lot #986429, Exp. 1/1/2024, UDI-DI 10195594961923; (35) Cat. SOP12HAUVE - Lot #64393, Exp. 11/1/2024, UDI-DI 10197106300657; (36) Cat. SOP12MJHM6 - Lot #922502, Exp. 12/1/2023, UDI-DI 10195594892081; (37) Cat. SOP22PSMRE - Lot #928986, Exp. 6/1/2024, UDI-DI 10888439917376; (38) Cat. SOP3LLESGK - Lot #959551, Exp. 4/1/2025 and Exp. 5/1/2025, UDI-DI 10195594495930; (39) Cat. SOP30ACSCG - Lot #929766, Exp. 3/1/2027, UDI-DI 10195594759780; (40) Cat. SOP30AKJTF - Lot #16244, Exp. 11/1/2027, UDI-DI 10197106080160; (41) Cat. SOP30FRUHE - Lot #986684, Exp. 12/1/2024, UDI-DI 10195594614263; (42) Cat. SOP30HALHB - Lot #924124, Exp. 12/1/2025, UDI-DI 10195594737351; (43) Cat. SOP30HPWME - Lot #991876, Exp. 6/1/2024, UDI-DI 10888439936414; (44) Cat. SOP30HSCHE - Lot #12487, Exp. 12/1/2024, UDI-DI 10888439853025; (45) Cat. SOP30OSVI8 - Lot #921913, Exp. 6/1/2027, UDI-DI 10195594891343; (46) Cat. SOP30UPOHD - Lot #929776, Exp. 10/1/2026, UDI-DI 10195594469139; (47) Cat. SOP32AHGMH - Lot #71002, Exp. 1/1/2027, UDI-DI 10197106088661; (48) Cat. SOP33ANOOI - Lot #998668, Exp. 4/1/2024, UDI-DI 10197106026588; (49) Cat. SOP33OROUJ - Lot #930189, Exp. 6/1/2024 and Exp. 5/1/2024, UDI-DI 10195594700683; (50) Cat. SOP33OROU5 - Lot #918471, Exp. 2/1/2024, UDI-DI 10195594876340; (51) Cat. SOP35AHAMG - Lot #923516, Exp. 4/1/2024, UDI-DI 10195594571696, (52) Cat. SOP41HISP6 - Lot #916958, Exp. 2/1/2024, UDI-DI 10195594873691; (53) Cat. SOP44STHPC - Lot #12393, Exp. 12/1/2024, UDI-DI 10888439912180; (54) Cat. SOP5BAHHEE - Lot #53599, Exp. 12/1/2024, UDI-DI 10195594532246; (55) Cat. SOP5BHSEHD - Lot #986063, Exp. 10/1/2024, UDI-DI 10888439654790; (56) Cat. SOP5CCJOUH - Lot #920091, Exp. 7/1/2024, UDI-DI 10195594663902; (57) Cat. SOP51BAKOF - Lot #966211, Exp. 10/1/2024, UDI-DI 10887488579931; (58) Cat. SOP51BAKO9 - Lot #927573, Exp. 6/1/2024, UDI-DI 10197106005507; (59) Cat. SOP53APKP4 - Lot #929995, Exp. 2/1/2024, UDI-DI 10197106012741; (60) Cat. SOP56HAMT8 - Lot #920050, Exp. 10/1/2023, UDI-DI 10195594882600; (61) Cat. SOP57AHSH5 - Lot #986901, Exp. 12/1/2024, UDI-DI 10197106133361; (62) Cat. SOP6VTHPOA - Lot #986320, Exp. 10/1/2024, UDI-DI 10195594408312; (63) Cat. SOP69AHKCF - Lot #915225, Exp. 3/1/2024, UDI-DI 10887488576046; (64) Cat. SOP69AHKC2 - Lot #912556, Exp. 3/1/2024, UDI-DI 10195594862879; (65) Cat. SOP69AHMRI - Lot #4205, Exp. 8/1/2024, Exp. 12/1/2024, and Exp. 6/1/2024, UDI-DI 10195594097295; (66) Cat. SOP69SHWMR - Lot #913072, Exp. 3/1/2024, UDI-DI 10195594106331; (67) Cat. SOP69TAKT3 - Lot #922930, Exp. 6/1/2024, UDI-DI 10195594892852; (68) Cat. SOP69TAKT6 - Lot #986238, Exp. 10/1/2024, UDI-DI 10197106133132; (69) Cat. SOP69TSKBA - Lot #986066, Exp. 1/1/2024, UDI-DI 10195594464431; (70) Cat. SOP73HAKPH - Lot #942491, Exp. 7/1/2024, UDI-DI 10195594446345; (71) Cat. SOP73SPDOC - Lot #970296, Exp. 2/1/2024, UDI-DI 10888439930733; and (72) Cat. SOP82AHBFK - Lot #18539, Exp. 7/1/2023 and Exp. 12/1/2023, UDI-DI 10888439974881.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

device · product 10 of 10

Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.

Z-0092-2024
Recall number
Z-0092-2024
Initiated
August 16, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13,351 total packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Code information

Lot #23520, Exp. 2/1/2025, UDI-DI 10888439920840.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

Field note

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