CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
FDA Recall #Z-1406-2025 — Class II — February 4, 2025
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.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
91 units
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated