BEUDAMED
    FDA Recall Open, Classified

    MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

    Recall: Z-0034-2025 · Initiated August 30, 2024

    Recall

    Recall Number
    Z-0034-2025
    Event Number
    95318
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    DXN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 30, 2024
    Posted
    October 8, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

    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.

    Action

    Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 08/30/2024 via email and USPS first class mail. The notice explained the problem, risk to user and requested that units demonstrating the failure be discarded. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]. Medline issued a follow up notification to distributors on 09/13/2024. The notification contained the same information as the initial letter, but also instructed distributors to notify customers if the product was further distributed.

    Distribution

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

    Quantity

    7,428 units