BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

    Recall: Z-0032-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0032-2025
    Event ID
    95318
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 16, 2024
    Initiation Date
    August 30, 2024
    Classification Date
    October 9, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

    Reason

    It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.

    Code Info

    GTIN 00888277629656, Lot Numbers: L230380005, L230480005, L230580005, L230680005, L230780005, L230980005, L231080005, L231180005, L231280005, L240280005

    Distribution

    Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.

    Quantity

    52,521 units