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U.S. Department of Health and Human Services

Safety

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Thermoflect Blankets and product line - Recall

Audience: Radiological healthcare professionals, hospital risk managers

[Posted 12/28/2009] Encompass Group and FDA notified healthcare professionals of the voluntary recall of the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment. FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. Encompass is in the process of sending labels to customers to be attached per instructions to remind hospitals that the product line should not be used in the MR environment. A complete list of Thermoflect products and additional information can be found at www.thermoflect.com.

[12/28/2009 - Press Release - Encompass Group]