BEUDAMED
    FDA Enforcement Class II Ongoing

    Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.

    Recall: Z-2634-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2634-2023
    Event ID
    92933
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Inmar Supply Chain Solutions, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    October 4, 2023
    Initiation Date
    August 24, 2023
    Classification Date
    September 25, 2023
    Address
    1131 W Bardin Rd Ste 131, N/A, Arlington, TX, 76017-6082, United States

    Description

    Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.

    Reason

    Various medical devices potentially exposed to rodent and rodent activity. In addition, medical devices may have been subjected to temperatures in excess of storage requirements on product labeling.

    Code Info

    Various

    Distribution

    US Nationwide distribution.

    Quantity

    unknown