BEUDAMED
    FDA Enforcement Class II Ongoing

    Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.

    Recall: Z-2531-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2531-2025
    Event ID
    97452
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AVID Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 17, 2025
    Initiation Date
    August 4, 2025
    Classification Date
    September 5, 2025
    Address
    9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States

    Description

    Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.

    Reason

    Potential for open header bag seals, compromising sterility.

    Code Info

    Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.

    Distribution

    US Nationwide distribution in the state of Florida.

    Quantity

    228 units