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Terminated

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

FDA Recall Z-1196-2008 · Posted 2008-03-08

Recalling FirmChattem Inc
Recall StatusTerminated
Product CodeIMD
Date Initiated2008-02-12
Date Terminated2009-10-05
Product Quantity666,636 units (total for Recalls Z-1196-1197-2008)

Reason for Recall

Skin irritation and burns with product usage

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide - USA, Canada, and Honduras

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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