BEUDAMED
    FDA Enforcement Class II Ongoing

    Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

    Recall: Z-2520-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2520-2025
    Event ID
    97394
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    O&M HALYARD INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2025
    Initiation Date
    July 17, 2025
    Classification Date
    September 4, 2025
    Address
    1220 Old Alpharetta Rd Ste 320, N/A, Alpharetta, GA, 30005-3946, United States

    Description

    Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

    Reason

    Surgical drape packs may have open seals, which may compromise the sterility of the product.

    Code Info

    Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)

    Distribution

    Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.

    Quantity

    1316