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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97358

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

Open FDA event record

Event summary

Timeline bucket
July 14, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
American Contract Systems Inc

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

9 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 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P; 5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F; 6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G; 7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F; 8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K; 9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H; 10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM; 11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D; 12) AV GRAFT RCH 0246952, MODEL/ITEM NUMBER RCAV40C; 13) OPEN HEART PART 1 RCH 0247159, MODEL/ITEM NUMBER RCOH61G; 14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T; 15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM; 16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD; 17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF; 18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH; 19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN; 20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S; 21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q; 22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL; 23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J; 24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E; 25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E; 26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F; 27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G.

Z-2464-2025
Recall number
Z-2464-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
31506 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) MODEL/ITEM NUMBER ANCV78BC: UDI/DI 00191072235169, Kit Lot Numbers: 42-7844511, 42-8133811, 42-8037211, 42-7952411, 42-7882011; 2) MODEL/ITEM NUMBER ANVA82AB: UDI/DI 00191072235183, Kit Lot Numbers: 42-8025011, 42-8108511, 42-7928511; 3) MODEL/ITEM NUMBER BHOP48O: UDI/DI 00191072221490, Kit Lot Numbers: 9207467, 8862838, 9140871, 9049946, 9007346, 8934280; 4) MODEL/ITEM NUMBER BHOP48P: UDI/DI 00191072234544, Kit Lot Numbers: 9268782, 9345847; 5) MODEL/ITEM NUMBER BHPH18F: UDI/DI 00191072224651, Kit Lot Numbers: 8993526, 9098058, 8899297; 6) MODEL/ITEM NUMBER BHPH18G: UDI/DI 00191072234551, Kit Lot Numbers: 9238544; 7) MODEL/ITEM NUMBER HGCB98F: UDI/DI 00191072205285, Kit Lot Numbers: 42-7813711; 8) MODEL/ITEM NUMBER HGCV05K: UDI/DI 00191072212474, Kit Lot Numbers: 42-8097611, 42-8021411, 42-7870011, 42-7831911, 42-8093211; 9) MODEL/ITEM NUMBER HGOH99H: UDI/DI 00191072235336, Kit Lot Numbers: 42-8119511, 42-8044311, 42-7874411; 10) MODEL/ITEM NUMBER MHCV10AM: UDI/DI 00191072235619. Kit Lot Numbers: 42-7848211; 11) MODEL/ITEM NUMBER MTVS73D: UDI/DI 00191072237583, Kit Lot Numbers: 12-7397911, 12-7335111, 12-7072111, 12-7142511, 12-7224911; 12) MODEL/ITEM NUMBER RCAV40C: UDI/DI 00191072235381, Kit Lot Numbers: 42-8053511, 42-8151011, 42-7978811, 42-7853911; 13) MODEL/ITEM NUMBER RCOH61G: UDI/DI 00191072229823, Kit Lot Numbers: 42-7803611, 42-7941711, 42-7997711, 42-8075711; 14) MODEL/ITEM NUMBER TNCA08T: UDI/DI 00191072235534, Kit Lot Numbers: 42-7827011, 42-8158811; 15) MODEL/ITEM NUMBER TNCB10AM: UDI/DI 00191072232991, Kit Lot Numbers: 42-7864811, 42-7971311, 42-8065311; 16) MODEL/ITEM NUMBER UDAV16AD: UDI/DI 00191072216229, Kit Lot Numbers: 42-7919811; 17) MODEL/ITEM NUMBER UDCP24AF: UDI/DI 00191072235305, Kit Lot numbers: 42-8010311, 42-8109811; 18) MODEL/ITEM NUMBER UDFP36AH: UDI/DI 00191072235329, Kit Lot Numbers: 42-7835011, 42-7902811, 42-8014011, 42-8091211; 19) MODEL/ITEM NUMBER UICD62AN: UDI/DI 00191072200495, Kit Lot Numbers: 42-7874211, 42-7934511, 42-7999011, 42-8072211, 42-8132211; 20) MODEL/ITEM NUMBER UICS88S: UDI/DI 00191072235428, Kit Lot Numbers: 42-7821511, 42-7913211, 42-7979011, 42-8032611, 42-8106011; 21) MODEL/ITEM NUMBER UIPD03Q: UDI/DI 00191072235435, Kit Lot Numbers: 42-8083011, 42-8154511; 22) MODEL/ITEM NUMBER UITC53AL: UDI/DI 00191072235572, Kit Lot Numbers: 42-7887011, 42-7993911, 42-8071411; 23) MODEL/ITEM NUMBER UIVA75J: UDI/DI 00191072235602, Kit Lot Numbers: 42-7994011, 42-8056011, 42-8114011, 42-7827411, 42-7916411; 24) MODEL/ITEM NUMBER UMCA14E: UDI/DI 00191072222510, Kit Lot Numbers: 334022, 9238536; 25) MODEL/ITEM NUMBER UMOH42E: UDI/DI 00191072222534, Kit Lot Numbers: 8860283; 26) MODEL/ITEM NUMBER UMOH42F: UDI/DI 00191072224712, Kit Lot Numbers: 9125072, 9044687, 8977422, 8925203, 9167965; 27) MODEL/ITEM NUMBER UMOH42G: UDI/DI 00191072234896, Kit Lot Numbers: 9202772, 9334223.

Distribution pattern

US distribution to states of: IL and LA

device · product 2 of 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;

Z-2465-2025
Recall number
Z-2465-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
1233 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) Model/Item Number CILC69L: UDI/DI 00191072235503, Kit Lot Numbers: 42-7937111, 42-8049311; 2) Model/Item Number HNLC80J: UDI/DI 00191072193650, Kit Lot Numbers: 42-8044511, 42-8118911, 42-7977011, 42-7803211; 3) Model/Item Number JKLC55H: UDI/DI 00191072235138, Kit Lot Numbers: 42-7814311; 4) Model/Item Number LLLA21K: UDI/DI 00191072233486, Kit Lot Numbers: 70-052582, 70-053048, 70-051564, 70-051373, 70-051163, 70-053446, 70-053776; 5) Model/Item Number MPGL15G: UDI/DI 00191072223197, Kit Lot Numbers: 5436916, 5436615

Distribution pattern

US distribution to states of: IL and LA

device · product 3 of 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.

Z-2466-2025
Recall number
Z-2466-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
1127 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) Model/Item Number ASCY24A: UDI/DI 00191072201621, Kit Lot Numbers: 12-7370111, 12-7388611, 12-7388611, 12-7139611, 12-7191911, 12-7231611, 12-7263911; 2) Model/Item Number BUCY78E: UDI/DI 00191072235350, Kit Lot Numbers: 42-7962811; 3) Model/Item Number LMCP22T: UDI/DI 00191072235510, Kit Lot Numbers: 42-8027411, 42-8106111, 42-7885511, 42-7823511; 4) Model/Item Number LMTU31T: UDI/DI 00191072235527, Kit Lot Numbers: 42-7987311, 42-8059311, 42-8112211, 42-7832311, 42-7845011, 42-7914911; 5) Model/Item Number SACY80S: UDI/DI 00191072233370, Kit Lot Numbers: 70-052954, 70-052248, 70-51139, 70-053309, 70-053805; 6) Model/Item Number SPUR64F: UDI/DI 00191072238764, Kit Lot Numbers: 12-7394711, 12-7328411, 12-7096811, 12-7168211.

Distribution pattern

US distribution to states of: IL and LA

device · product 4 of 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item Number HSCY13M; 5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K; 6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H; 7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D; 8) PDA LF SJW, Model/Item Number SWPD12K; 9) AAA PACK - 206038, Model/Item Number UDAA63AH; 10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF; 11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX; 12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD; 13) PROCUREMENT PACK, Model/Item Number UIPC89D; 14) THYROID PACK (PS 096552), Model/Item Number UITR45W; 15) TRAUMA PACK 175634, Model/Item Number UMTR17B; 16) TRAUMA PACK 175634, Model/Item Number UMTR17C.

Z-2467-2025
Recall number
Z-2467-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
6617 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) Model/Item Number ANCV67X: UDI/DI 00191072203021, Kit Lot Numbers: 42-7789611, 42-8074911, 42-7925811, 42-8005111; 2) Model/Item Number ANKP15AD: UDI/DI 00191072235176, Kit Lot Numbers: 42-7916611, 42-8047711; 3) Model/Item Number FYLA38G: UDI/DI 00191072003706, Kit Lot Numbers: 42-7905711, 42-8134111; 4) Model/Item Number HSCY13M: UDI/DI 00191072005571, Kit Lot Numbers: 42-8125311, 42-7959411; 5) Model/Item Number HSDR10K: UDI/DI 00191072005588, Kit Lot Numbers: 42-7984111, 42-7883711; 6) Model/Item Number HSMD20H: UDI/DI 00191072237262, Kit Lot Numbers: 42-7937911; 7) Model/Item Number PDSA12D: UDI/DI 00191072137111, Kit Lot Numbers: 70-053496; 8) Model/Item Number SWPD12K: UDI/DI 00191072228512, Kit Lot Numbers: 5437920, 5436824, 5436860, 5437058, 5437174, 5437197, 5437211, 5437326, 5437390, 5437696, 5437720, 5437752, 5437800, 5437859, 5438008, 5438056, 5438066, 5438331, 5438336, 5438446, 5438033 , 5438535; 9) Model/Item Number UDAA63AH: UDI/DI 00191072235275, Kit Lot Numbers: 42-8052111, 42-8104211; 10) Model/Item Number UDBC35AF: UDI/DI 00191072103420, Kit Lot Numbers: 42-7867111, 42-7940911, 42-7981511; 11) Model/Item Number UDBH37AX: UDI/DI 00191072012098, Kit Lot Numbers: 42-7867811, 42-7947511, 42-8007611, 42-8032411; 12) Model/Item Number UIFF72AD: UDI/DI 00191072235541, Kit Lot Numbers: 42-7849111, 42-7947711, 42-8024111, 42-8095211; 13) Model/Item Number UIPC89D: UDI/DI 00191072205742, Kit Lot Numbers: 42-8024311, 42-8113911; 14) Model/Item Number UITR45W: UDI/DI 00191072235589, Kit Lot Numbers: 42-7875311, 42-7980811, 42-8067111; 15) Model/Item Number UMTR17B: UDI/DI 00191072222596, Kit Lot Numbers: 9124674, 8925186, 9003138, 9051991 16) Model/Item Number UMTR17C: UDI/DI 00191072233806, Kit Lot Numbers: " 9202780, 9292532.

Distribution pattern

US distribution to states of: IL and LA

device · product 5 of 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.

Z-2468-2025
Recall number
Z-2468-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
204 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) MODEL/ITEM NUMBER UICR10W: UDI/DI 00191072207241, Kit Lot Numbers: 42-7828711, 42-7980711, 42-8063211, 42-8124011; 2) MODEL/ITEM NUMBER UISH55V: UDI/DI 00191072235442, Kit Lot Numbers: 42-7799111, 42-7985211, 42-8065111, 42-8140711.

Distribution pattern

US distribution to states of: IL and LA

device · product 6 of 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.

Z-2469-2025
Recall number
Z-2469-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
781 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) Model/Item Number LLBN11C: UDI/DI 00191072233530, Kit Lot Numbers: 70-051710, 70-052354; 2) Model/Item Number LLLD19I: UDI/DI 00191072233493, Kit Lot Numbers: 70-051324, 70-051967, 70-053006, 70-053303, 70-053710.

Distribution pattern

US distribution to states of: IL and LA

device · product 7 of 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.

Z-2470-2025
Recall number
Z-2470-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
1094 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) MODEL/ITEM NUMBER EVLP61I: UDI/DI 00191072194831, Kit Lot Numbers: 12-7359211, 12-7077211 , 12-7115211, 12-7162811, 12-7224111, 42-8276811, 42-8200111; 2) MODEL/ITEM NUMBER EVPV29G: UDI/DI 00191072194930, Kit Lot Numbers: 12-7288711, 12-7288711

Distribution pattern

US distribution to states of: IL and LA

device · product 8 of 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.

Z-2471-2025
Recall number
Z-2471-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) MODEL/ITEM NUMBER GRRB10E: UDI/DI 00191072236371, Kit Lot Numbers: 42-8157011, 42-8126811; 2) MODEL/ITEM NUMBER SPVH62P: UDI/DI 00191072238771, Kit Lot Numbers: 12-7322911, 12-7384911.

Distribution pattern

US distribution to states of: IL and LA

device · product 9 of 9

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.

Z-2472-2025
Recall number
Z-2472-2025
Initiated
July 14, 2025
Classification
Class II
Status
Ongoing
Quantity
588 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information

1) MODEL/ITEM NUMBER AMAH40N: UDI/DI 00191072235473, Kit Lot Numbers: 42-7886011, 42-7990911; 2)MODEL/ITEM NUMBER CCKM67F: UDI/DI 00191072233578, Kit Lot Numbers: 70-053862, 70-053457, 70-053042, 70-052715, 70-052358, 70-051850, 70-051243; 3)MODEL/ITEM NUMBER HSTH03N: UDI/DI 00191072189615, Kit Lot Numbers: 42-7115711; 4)MODEL/ITEM NUMBER MIAH65B: UDI/DI 00191072235411, Kit Lot Numbers: 42-8134311; 5)MODEL/ITEM NUMBER MPWH01B: UDI/DI 00191072233271, Kit Lot Numbers: 5436801; 6)MODEL/ITEM NUMBER SPKA57T: UDI/DI 00191072235848, Kit Lot Numbers: 12-7400011, 12-7381311, 12-7358211, 12-7082111, 12-7157111, 12-7309911; 7)MODEL/ITEM NUMBER WVAH40H: UDI/DI 00191072233004, Kit Lot Numbers: 42-7897411, 42-7966211.

Distribution pattern

US distribution to states of: IL and LA

Field note

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