RecallDepth

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

Company
Chattem Inc
Recall Initiated
February 12, 2008
Posted
March 8, 2008
Terminated
October 5, 2009
Recall Number
Z-1197-2008
Quantity
666,636 units (total for Recalls Z-1196-1197-2008)
Firm Location
Chattanooga, TN

Reason for Recall

Skin irritation and burns with product usage

Distribution

Worldwide - USA, Canada, and Honduras

Lot / Code Info

All Lots

Root Cause

Device Design

Action Taken

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.

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