Recall Z-1197-2008 ยท IMD Pack, Hot Or Cold, Disposable
Chattem Inc
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
| Date | Mar 8, 2008 (initiated Feb 12, 2008) |
| Status | Terminated |
| Reason | Skin irritation and burns with product usage |
| Root cause | 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 | 666,636 units (total for Recalls Z-1196-1197-2008) |
| Distribution | Worldwide - USA, Canada, and Honduras |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.