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American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYS
Recalled September 3, 2025 · FDA recall Z-2466-2025 · 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
1127 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) 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 SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.
Manufacturer(s)
American Contract Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →