medical Class II Updated 2019-06-05

PF Consumer Healthcare 1 LLC recalls ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a)

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: a) S23902 b) W37940 c) S00639
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →