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U.S. Department of Health and Human Services

Class 2 Device Recall Ace Heat Therapy

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 Class 2 Device Recall Ace Heat Therapysee related information
Date Initiated by FirmApril 25, 2008
Date PostedSeptember 26, 2008
Recall Status1 Terminated 3 on March 27, 2009
Recall NumberZ-2431-2008
Recall Event ID 49086
Product Classification Disposable Hot Pack - Product Code IMD
ProductAce 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.
Code Information All lots  Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactWafa Al-Rimawi
201-847-6795
Manufacturer Reason
for Recall		Potential for skin irritation and burns associated with the use of this product.
FDA Determined
Cause 2		Device Design
ActionImportant: 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 in Commerceapproximately 703,000 patches
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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