BEUDAMED
    FDA Recall Terminated

    Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm) each, 1 and 4 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219

    Recall: Z-1197-2008 · Initiated February 12, 2008

    Recall

    Recall Number
    Z-1197-2008
    Event Number
    46784
    Firm
    Chattem Inc
    FEI Number
    1022556
    Product Code
    IMD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 12, 2008
    Posted
    March 8, 2008
    Terminated
    October 5, 2009
    Address
    1715 W 38th St, Chattanooga, TN, 37409-1248

    Description

    Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm) each, 1 and 4 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219

    Reason

    Skin irritation and burns with product usage

    Action

    The firm initiated its recall on 02/08/2008 by issuing a press release warning the public of the hazard and directing them to stop its use and either return or discard the products. The firm initiated the recall at the retail level on 02/12/2008 by notifying its employee sales force by email, containing a Urgent Medical Device Recall Letter, with instructions to immediately email a copy of the recall letter to each Chattem consignee (wholesalers and direct retail accounts) with sub recall requests.

    Distribution

    Worldwide - USA, Canada, and Honduras

    Quantity

    666,636 units (total for Recalls Z-1196-1197-2008)