BEUDAMED
    FDA Enforcement Class II Ongoing

    Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    Recall: Z-0027-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0027-2025
    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 Tray REF AMS9300A 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: AMS9300A UDI-DI code: B098AMS9300A0 Lot Numbers: 168030 171362 172981 177913 179608 181537 185126 189873 189874 196460 196461 198850 200902 206846 208255 209391

    Distribution

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

    Quantity

    642 kits