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U.S. Department of Health and Human Services

Class 2 Device Recall ThermaCare HEATWRAPS

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  Class 2 Device Recall ThermaCare HEATWRAPS see related information
Date Initiated by Firm April 26, 2019
Create Date May 28, 2019
Recall Status1 Completed
Recall Number Z-1495-2019
Recall Event ID 82781
Product Classification Pack, hot or cold, disposable - Product Code IMD
Product ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.
Code Information Lot Number S97473
Recalling Firm/
Manufacturer		 PF Consumer Healthcare 1 LLC
1231 Wyandotte Dr
Albany GA 31705-3815
For Additional Information Contact Kim Bencker
610-329-1340
Manufacturer Reason
for Recall		 There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures poses a potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap-applied area.
FDA Determined
Cause 2		 Other
Action The firm initiated the recall by press release on 04/26/2019. Notification packages to direct consignees were sent on 04/29/2019. The consignees were directed to cease distribution and return the product. Distributors were directed to sub-recall. Retailers were asked to post the press release either at the cash register or another prominent location.
Quantity in Commerce 155,904 individual HeatWraps
Distribution Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland.
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.
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