Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-2431-2008 · Posted 2008-09-26

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeIMD
Date Initiated2008-04-25
Date Terminated2009-03-27
Product Quantityapproximately 703,000 patches

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

↑