AMERICAN CONTRACT SYSTEMS — Class II medical device recall Z-2464-2025
Ongoing recall by American Contract Systems Inc, reported 2025-09-03, distributed in IL, LA. During an internal investigation, ACS determined that the rationale for sterilization of certain components wa
| Recall number | Z-2464-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems Inc, Tiffin, OH, United States |
| Recall initiated | 2025-07-14 |
| Classified | 2025-08-28 |
| Reported by FDA | 2025-09-03 |
| Distributed | IL, LA |
| Quantity | 31,506 units |
| UPC / GTIN / UDI-DI | 00191072200495, 00191072205285, 00191072212474, 00191072216229, 00191072221490, 00191072222510, 00191072222534, 00191072224651, 00191072224712, 00191072229823, 00191072232991, 00191072234544, 00191072234551, 00191072234896, 00191072235169, 00191072235183, 00191072235305, 00191072235329, 00191072235336, 00191072235381, 00191072235428, 00191072235435, 00191072235534, 00191072235572, 00191072235602 and 2 more |
| Lot numbers | 12-7072111, 12-7142511, 12-7224911, 12-7335111, 12-7397911, 334022, 42-7803611, 42-7813711, 42-7821511, 42-7827011, 42-7827411, 42-7831911, 42-7835011, 42-7844511, 42-7848211, 42-7853911, 42-7864811, 42-7870011, 42-7874211, 42-7874411, 42-7882011, 42-7887011, 42-7902811, 42-7913211, 42-7916411, 42-7919811, 42-7928511, 42-7934511, 42-7941711, 42-7952411, 42-7971311, 42-7978811, 42-7979011, 42-7993911, 42-7994011, 42-7997711, 42-7999011, 42-8010311, 42-8014011, 42-8021411 and 45 more |
| Model numbers | 0247159, ANCV78BC, ANVA82AB, BHOP48O, BHOP48P, BHPH18F, BHPH18G, HGCB98F, HGCV05K, HGOH99H, MHCV10AM, MTVS73D, RCAV40C, RCOH61G, TNCA08T, TNCB10AM, UDAV16AD, UDCP24AF, UDFP36AH, UICD62AN, UICS88S, UIPD03Q, UITC53AL, UIVA75J, UMCA14E and 3 more |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2464-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.