BEUDAMED
    FDA Enforcement Class II Ongoing

    Thermalon Sinus Compress, Item Number 24332

    Recall: Z-1361-2024 · Reported April 3, 2024

    Enforcement

    Recall Number
    Z-1361-2024
    Event ID
    94120
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bruder Healthcare Company, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 3, 2024
    Initiation Date
    February 21, 2024
    Classification Date
    March 22, 2024
    Address
    1115 Ridgeland Pkwy Ste 101, N/A, Alpharetta, GA, 30004-8409, United States

    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.

    Code Info

    UPC 041533243328, Lot Numbers: M053160, M053570

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    1416 units