Recall Z-2431-2008 ยท IMD Pack, Hot Or Cold, Disposable
Becton Dickinson & Company
Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain. Apply Directly to Skin, Instant, Air-Activated Heat Patches Distributed by: BD Medical, Franklin Lakes, NJ 07417 Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586.
| Date | Sep 26, 2008 (initiated Apr 25, 2008) |
| Status | Terminated |
| Reason | Potential for skin irritation and burns associated with the use of this product. |
| Root cause | Device Design |
| Action | Important: Product Recall Letters were sent by UPS second day air with tracking on April 25, 2008 to all customers asking them to please contact Customer Service at 866-228-7265 to have a Return Goods Authorization issued. The letter also states that neither customers nor a third party should destroy product. |
| Quantity | approximately 703,000 patches |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.