—#72726

Product

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.

FDA product code: IMD — Pack, Hot Or Cold, Disposable
Device class: Class 1
Medical specialty: Physical Medicine
Affected lot / code info: All lots Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586.

Why it was recalled

Potential for skin irritation and burns associated with the use of this product.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-04-25
Posted by FDA: 2008-09-26
Terminated: 2009-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.