medical Class II Updated 2025-03-26

American Contract Systems Inc recalls CRANI PACK, Model/Catalog Number WECR41D, medical procedure

Recalled Product

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.


Hazard / Issue

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.

Issued by

FDA

Affected States: MI
Lot/Code Info: 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
View official government recall

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