AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Numb
Pending LLM rewrite. Source: FDA_DEVICE Z-2466-2025.
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) 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 SA
- 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 ASCY24A: UDI/DI 00191072201621
- Kit Lot Numbers: 12-7370111
- 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
Distribution
Distributed in 2 states:
- IL
- LA
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