BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1406-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1406-2025
    Event ID
    96332
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 26, 2025
    Initiation Date
    February 4, 2025
    Classification Date
    March 20, 2025
    Address
    85 Shaffer Park Dr, N/A, Tiffin, OH, 44883-9290, United States

    Description

    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.

    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

    Distribution

    US: MI

    Quantity

    91 units