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American Contract Systems Inc recalls CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Recalled March 26, 2025 · FDA recall Z-1406-2025 · American Contract Systems
Hazard
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures. · FDA Class II
Units
91 units
Sold at
US: MI
Description
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
Product
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Manufacturer(s)
American Contract Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →