ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B 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.
FDA Recall Z-1496-2019 · Posted None
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Recalling FirmPF Consumer Healthcare 1 LLC
Recall StatusTerminated
Product CodeIMD
Date Initiated2019-04-26
Date Terminated2024-06-11
Product Quantity225617 individual heat wraps
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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