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U.S. Department of Health and Human Services

Class 2 Device Recall Icy Hot Heat Therapy

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  Class 2 Device Recall Icy Hot Heat Therapy see related information
Date Initiated by Firm February 12, 2008
Date Posted March 08, 2008
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-1196-2008
Recall Event ID 46784
Product Classification Air Activated Heat Patch - Product Code IMD
Product Icy Hot Heat Therapy , Air Activated Heat Patch, Back and Large Areas, UPC Code 0-41167-08330-7, Product Code 08330, 4.1" x 8.4" (10.5 cm x 2.1 cm) each, 1 and 3 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219
Code Information All Lots
Recalling Firm/
Manufacturer		 Chattem Inc
1715 W 38th St
Chattanooga TN 37409-1248
For Additional Information Contact Ms. Catherine Baker
423-822-3209
Manufacturer Reason
for Recall		 Skin irritation and burns with product usage
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 666,636 units (total for Recalls Z-1196-1197-2008)
Distribution Worldwide - USA, Canada, and Honduras
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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