BEUDAMED
    FDA Recall Open, Classified

    Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.

    Recall: Z-2530-2025 · Initiated August 4, 2025

    Recall

    Recall Number
    Z-2530-2025
    Event Number
    97452
    Firm
    AVID Medical, Inc.
    FEI Number
    1047429
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 4, 2025
    Posted
    September 5, 2025
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351

    Description

    Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.

    Reason

    Potential for open header bag seals, compromising sterility.

    Action

    Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.

    Distribution

    US Nationwide distribution in the state of Florida.

    Quantity

    57 units