Recently, Encompass Group issued a voluntary recall of its Thermoflect product line. Thermoflect products are used to treat hypothermia. The company is recalling the products for relabeling regarding the use of Thermoflect in the Magnetic Resonance (MR) environment. At this time, the company is asking that Thermoflect not be used in MR conditional or MR compatible environments. New labeling will be issued reminding hospitals not to use Thermoflect in the MR environment. Encompass Group had marketed its Thermoflect products are MR-conditional and MR-compatible. Howver, according to the company, it received information from the FDA not to promote Thermoflect for use in MR environments. The FDA has received a report of an injury to an MRI patient, and a Thermoflect blanket used in the MR environment is one of the items under consideration as a possible cause of the injury. Encompass is informing customers of the Thermoflect recall though the news release, magazine and trade paper listings, as well as letters to customers, doctors and hospitals. Thermoflect products are distributed nationally and internationally.
Comments are closed.