BEUDAMED
    FDA Recall Open, Classified

    Thermalon Sinus Compress, Item Number 24332

    Recall: Z-1361-2024 · Initiated February 21, 2024

    Recall

    Recall Number
    Z-1361-2024
    Event Number
    94120
    Firm
    Bruder Healthcare Company, LLC
    FEI Number
    1039131
    Product Code
    IMA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 21, 2024
    Posted
    March 22, 2024
    Address
    1115 Ridgeland Pkwy, Ste 101, Alpharetta, GA, 30004-8409

    Description

    Thermalon Sinus Compress, Item Number 24332

    Reason

    Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

    Action

    Bruder Healthcare Company sent an email to its consignees on XXX to notify them of the recall. The email explained the issue and requested the consignees cease distribution of affected stock and contact Bruder Healthcare Company for instructions on returning the product. Distributors were directed to forward the recall communication to their customers.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    1416 units