Recall : The entire “Thermoflect” product line used in MR environments

The Encompass Group announced they are voluntarily recalling the entire Thermoflect product line. This product was used in MR (Magnetic Resonance) environments, but is being pulled back for “relabeling”.

Encompass Group Corporate Compliance Officer Jea R. 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.”

Wait… what? Thermoflect blankets and covers were used in MR (Magnetic Resonance) environments before, and now they’re suddenly not?

Gackowski said that in the past they stated their Thermoflect product was indeed OK to use in MR environments, and their product is still great for treating hypothermia, but “…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.”

Yikes. I smell a lawsuit. A big, nasty one too. And the Encompass Group is implementing plan “CYA”.

Here’s the link to the FDA notice.

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