BEUDAMED
    FDA Recall Open, Classified

    Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS

    Recall: Z-1487-2024 · Initiated March 5, 2024

    Recall

    Recall Number
    Z-1487-2024
    Event Number
    94210
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    QTC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 5, 2024
    Posted
    April 5, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS

    Reason

    Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails) and failed to meet all mandatory requirements outlined in these standards.

    Action

    Medline Industries, LP issued a Medical Device Recall Notice to its consignees on 03/05/2024 via USPS first class mail and email. The notice explained the issue with the device and requested the consignee destroy the device. Distributors were directed to notify their customers.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    2895 devices