FOR IMMEDIATE RELEASE – December 26, 2009 – McDonough, GA – 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.
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"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.
Read more...
Tags: Safety, Thermoflect blanket, hypothermia
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