AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK -
Pending LLM rewrite. Source: FDA_DEVICE Z-2467-2025.
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) 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 N
- 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 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
Distribution
Distributed in 2 states:
- IL
- LA
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