BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2407-2026 · Initiated April 30, 2026

    Recall

    Recall Number
    Z-2407-2026
    Event Number
    99021
    Firm
    AVID Medical, Inc.
    FEI Number
    1047429
    Product Code
    OJH
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 30, 2026
    Posted
    June 11, 2026
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351

    Description

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

    Reason

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

    Action

    AVID Medical notified consignees on about 04/30/2026 via emailed letter. Consignees were instructed to identify, segregate and quarantine all affected units on hand, discard all impacted kits and complete and return the provided Response Form. Distributors were instructed to ensure all end-users are appropriately notified and maintain records of effectiveness.

    Distribution

    US Nationwide distribution in the state of Iowa.

    Quantity

    120 kits