Recall Z-1406-2025— American Contract Systems Inc
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems Inc, initiated 2025-02-04. FDA's recall record names no specific 510(k) clearance for this event. Product: CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.. Reason: 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..
- Recalling firm
- American Contract Systems Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-04
- Firm location
- Tiffin, OH, United States
Product description
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.