Class 2 Device Recall ThermaCare HEATWRAPS

• Date Initiated by Firm: April 26, 2019
• Create Date: May 28, 2019
• Recall Status: Terminated on June 11, 2024
• Recall Number: Z-1496-2019
• Recall Event ID: 82781
• Product Classification: Pack, hot or cold, disposable - Product Code IMD
• Product: 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.
• Code Information: Lot Numbers: a) S23902 b) W37940 c) S00639
• 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: 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: 225617 individual heat wraps
• 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.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.