BEUDAMED
    FDA Recall Open, Classified

    CURAD REUSABLE GEL HOT/COLD PACK

    Recall: Z-0633-2022 · Initiated December 15, 2021

    Recall

    Recall Number
    Z-0633-2022
    Event Number
    89235
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    IME
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 15, 2021
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    CURAD REUSABLE GEL HOT/COLD PACK

    Reason

    The product contains natural rubber latex but the label states that it does not.

    Action

    The firm initiated the recall by letter on 12 December 2021. The letter explained the issue and requested destruction of the product. Any entity transferring the product was required to notify their customers.

    Distribution

    US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla

    Quantity

    494,273 ea