AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, M
Pending LLM rewrite. Source: FDA_DEVICE Z-2464-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- 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, M
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 2 states:
- IL
- LA
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