BEUDAMED
    FDA Enforcement Class II Ongoing

    Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    Recall: Z-0031-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0031-2025
    Event ID
    95306
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2024
    Initiation Date
    August 16, 2024
    Classification Date
    October 8, 2024
    Address
    1602 4th Ave N, Billings, MT, 59101-1521, United States

    Description

    Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    Reason

    Due to convenience kits containing a kit component that is under a recall action for improper use.

    Code Info

    Catalog Number: AMS14809 UDI-DI code: B098AMS148090 Lot Numbers: 192737 194922 200224 200950 203412

    Distribution

    U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

    Quantity

    180 packs