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American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L;
Recalled September 3, 2025 · FDA recall Z-2465-2025 · American Contract Systems
Hazard
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. · FDA Class II
Units
1233 units
Sold at
US distribution to states of: IL and LA
Description
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.
Product
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;
Manufacturer(s)
American Contract Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →