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U.S. Department of Health and Human Services

Class 2 Device Recall ThermaCare Menstrual 8 Hour Heat Wraps

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  Class 2 Device Recall ThermaCare Menstrual 8 Hour Heat Wraps see related information
Date Initiated by Firm September 24, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on September 16, 2011
Recall Number Z-0622-2011
Recall Event ID 56855
Product Classification Pack, hot or cold, disposable - Product Code IMD
Product ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609
Code Information Lot number: E06831 (Exp 8/2012); The lot number on the 3 ct cartons may be followed by an "N" or "S", for example, E06831 "N" or E06831 "S"
Recalling Firm/
Manufacturer		 Pfizer Global
5 Giralda Farms
Madison NJ 07940
Manufacturer Reason
for Recall		 The chemical components contained in the heat wrap may leak directly onto the skin, which could cause skin injury, including burns.
FDA Determined
Cause 2		 Packaging process control
Action Wyeth Consumer Healthcare issued an Urgent Voluntary Medical Device Recall letter dated September 24, 2010 to direct accounts, and issued a press release. The firm is removing the product in question from store shelves and asking consumers who have purchased the product to record the lot number, throw the product away in its entirety without opening the foil pouch and call 1 800 232-3383 for replacement. Direct accounts were instructed to remove the affected product from sale and return it immediately. If they further distributed the product they were instructed to notify their customers of the recall and request return of the products to them credit. Instructions were provided in the event consumers inquired about the recall. A prepaid post card was enclosed to record the quantity on hand to be returned.
Quantity in Commerce 192000 cartons (3 wraps per carton)
Distribution Nationwide Distribution: Throughout the U.S. and Puerto Rico.
Total Product Life Cycle TPLC 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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