Thermoflect Blankets, Other Products Recalled Following MRI Injury

<"">Thermoflect heat reflecting blankets and other products in the Thermoflect lines are being recalled today because of a possible risk of MRI injuries. According to a notice posted on the Food & Drug Administration Web site, the Thermoflect products will relabeled to reflect incompatibility with use in “magnetic resonance (MR) environments.”

The Thermoflect line includes blankets, gowns, and dressings used in preventing hypothermia. According to a statement from Encompass Group, the Thermoflect products are still safe and effective for use in treating hypothermia.

In the past, Encompass Group has stated that Thermoflect blankets and other products may be used in an MR environment. However, the company has now been advised of an injury to an MRI patient. The FDA is investigating several items, including a Thermoflect blanket as a contributor to the injury. However, there is no evidence that the Thermoflect blanket caused the injury, and the recall and relabeling effort are being carried out as a precautionary measure, Encompass Group said.

According to the company’s statement, there is currently no ASTM International standard to test Thermoflect in the MR environment. “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,” the Encompass Group statement said.

Encompass Group is requesting that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. The firm is also in the process of sending replacement product labels to hospitals to remind staff that the product is not considered safe for use in MRI.

Finally, the Encompass Group statement said the firm has sent letters to customers, hospitals, and doctors in radiology regarding the Thermoflect recall, and will follow up with training and verification surveys.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.