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Class 2 Device Recall Ace Heat Therapy |
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Date Initiated by Firm |
April 25, 2008 |
Date Posted |
September 26, 2008 |
Recall Status1 |
Terminated 3 on March 27, 2009 |
Recall Number |
Z-2431-2008 |
Recall Event ID |
49086 |
Product Classification |
Disposable Hot Pack - Product Code IMD
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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. |
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
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For Additional Information Contact |
Wafa Al-Rimawi 201-847-6795
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Manufacturer Reason for Recall |
Potential for skin irritation and burns associated with the use of this product.
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FDA Determined Cause 2 |
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 in Commerce |
approximately 703,000 patches |
Distribution |
Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
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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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