Z-1406-2025 Class II Ongoing
FDA device recall Z-1406-2025 was initiated by American Contract Systems Inc on February 4, 2025 and is designated Class II. 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 p… The recall status is ongoing. Affected quantity: 91 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 91 units
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.
Distribution Pattern
US: MI
Code Information
Lot Code: UDI: 191072216984, Lot Cocdes: 71-052536, Exp: 10/30/2025; 71-051491, Exp: 07/16/2025; LOT: 71-051609, Exp: 07/30/2025; 71-051767, Exp: 08/14/2025; 71-053065, Exp: 12/10/2025