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Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain. Apply Directly t

FDA device recall Z-2431-2008 · posted 2008-09-26 · Terminated

Recall details

Recalling firm
Becton Dickinson & Company
Reason for recall
Potential for skin irritation and burns associated with the use of this product.
Action taken
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
Status
Terminated
Product code
IMD
Quantity affected
approximately 703,000 patches
Distribution
Nationwide Distribution.
Date initiated
2008-04-25
Date posted
2008-09-26
Date terminated
2009-03-27
Location
Franklin Lakes, NJ

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