BEUDAMED
    FDA Enforcement Class II Ongoing

    Halyard, Pain Pack. Kit Code: AMPK48-01.

    Recall: Z-2407-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2407-2026
    Event ID
    99021
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AVID Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2026
    Initiation Date
    April 30, 2026
    Classification Date
    June 11, 2026
    Address
    9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States

    Description

    Halyard, Pain Pack. Kit Code: AMPK48-01.

    Reason

    Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

    Code Info

    Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028.

    Distribution

    US Nationwide distribution in the state of Iowa.

    Quantity

    120 kits