Device product
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Z-1406-2025
Product summary
- Event
- Event 96332
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 91 units
- Official record key
device-enforcement:Z-1406-2025
Official wording
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.
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
Distribution pattern: US: MI
Derived failure modes
-
Unknown
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.