Jea R. Gackowski, Encompass Group Corporate Compliance Officer announced today the company is voluntarily recalling the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment.
“We are voluntarily recalling the product line from use in the Magnetic Resonance (MR) environment,” Gackowski said. “We are requesting that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. We are in the process of sending labels to our customers to be attached per instructions to remind the hospitals that the product line should not be used in the MR environment.
“In the past, we have stated that the Thermoflect product may be used in the MR environment. However, after being informed by the FDA, at this time we will not promote the products for use in the Magnetic Resonance Environment. However, the product is still safe and effective for use in treating hypothermia.”
We have been advised by the FDA that a report has been filed of an injury to an (MRI) patient. Several items are under consideration, including all of the blankets used in the MRI environment, of which Thermoflect is one. There is no evidence that the Thermoflect blanket caused the injury but as a precautionary measure we are voluntarily recalling the product line for relabeling.
Thermoflect products are distributed nationally and internationally. A complete list of Thermoflect products and additional information can be found at www.thermoflect.com.
We have concluded that there is currently no ASTM International standard to test Thermoflect in the MR environment, although we have conducted multiple laboratory and field tests. “Until an ASTM standard has been developed by ASTM International, we have removed statements on our website and in our product literature that Thermoflect is MR-Conditional or MR-Compatible.
“In addition to issuing this news release to appropriate magazine and trade paper listings, we have sent letters to our customers, hospitals, and doctors in radiology and will follow up with training and verification surveys.”
“At Encompass Group, our mission is always to help healthcare and hospitality providers create safe and comfortable environments for patients, staff, residents and guests. This voluntary recall is another example of our ongoing commitment to those objectives”
For More Information, contact
Jea R. Gackowski, C.H.B., C.C.S.
Corporate Compliance Officer
Monday – Friday 9 a.m. – 5 p.m. eastern