BEUDAMED
    FDA Recall Terminated

    Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain. Apply Directly to Skin, Instant, Air-Activated Heat Patches Distributed by: BD Medical, Franklin Lakes, NJ 07417 Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586.

    Recall: Z-2431-2008 · Initiated April 25, 2008

    Recall

    Recall Number
    Z-2431-2008
    Event Number
    49086
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    IMD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 25, 2008
    Posted
    September 26, 2008
    Terminated
    March 27, 2009
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain. Apply Directly to Skin, Instant, Air-Activated Heat Patches Distributed by: BD Medical, Franklin Lakes, NJ 07417 Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586.

    Reason

    Potential for skin irritation and burns associated with the use of this product.

    Action

    Important: Product Recall Letters were sent by UPS second day air with tracking on April 25, 2008 to all customers asking them to please contact Customer Service at 866-228-7265 to have a Return Goods Authorization issued. The letter also states that neither customers nor a third party should destroy product.

    Distribution

    Nationwide Distribution.

    Quantity

    approximately 703,000 patches