FDA recall Z-1496-2019

PF Consumer Healthcare 1 LLC · Class II · device

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.

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.

Distribution

Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland.

Key facts

Status
Terminated
Initiation date
2019-04-26
Report date
2019-06-05
Termination date
2024-06-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Albany, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1496-2019