BEUDAMED
    FDA Enforcement Class II Ongoing

    Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

    Recall: Z-1338-2026 · Reported February 18, 2026

    Enforcement

    Recall Number
    Z-1338-2026
    Event ID
    98298
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AVID Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 18, 2026
    Initiation Date
    January 2, 2026
    Classification Date
    February 9, 2026
    Address
    9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States

    Description

    Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

    Reason

    Tyvek bag seal issue which may compromise sterility of the kit.

    Code Info

    Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028

    Distribution

    US Nationwide distribution in the states of New Jersey.

    Quantity

    1,500 units