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U.S. Department of Health and Human Services

Class 2 Device Recall Thermoflect

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 Class 2 Recall
Thermoflect
see related information
Date Posted March 22, 2010
Recall Status1 Terminated on October 27, 2010
Recall Number Z-1175-2010
Recall Event ID 54134
Product Classification Gown, Examination - Product Code FME
Product Thermoflect Product Line including items for adults and pediatrics.
Code Information All Thermoflect items, all codes.
Recalling Firm/
Manufacturer
Encompass Group LLC
615 Macon St
Mcdonough, Georgia 30253-3531
Consumer Instructions No consumer action necessary
For Additional Information Contact Jea R. Gackowski
770-626-2015
Manufacturer Reason
for Recall
The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action A press release distributed through specialized news media, and trade magazines, on/about 12/26/2009. The press release was also posted on the thermoflect.com website. Letters were sent via first class mail to customers, hospitals and doctors in radiology on/about 12/23/2009. In addition to the written notification to the user institutions, Encompass provided adhesive labels sent along with the letter notification. The notice instructed that the labels should be affixed to remaining inventories of the products(s), specifically to the individual package, which holds 5 blankets and to the outermost packaging or carton. The label reads Not for use in MRI, and a symbol showing a circle with a diagonal line through the letters MR. Thermoflect product literature has been quarantine at this time. Instructions were provided showing where the labels where the labels were to be affixed. Encompass also provided a poster indicating the products are for use in the MR environment which is to be displayed in the MR area. All new product literature will indicate that the product is not for ruse in the MR environment. Thermoflect sales representatives will visit with each user institution to confirm their receipt of the recall notice and to be available to answer any question concerning the recall. The sales representatives all of whom have been briefed on the recall strategy will be available to provide training for Radiation Safety Officers and radiology staff, if requested. Following the recall notice, Encompass will conduct Effectiveness Checks to assure that all purchasers/users of the Thermoflect product have been notified and have taken appropriate action to notify their radiology centers and staff. The Encompass recall team will maintain records of the contacts for review by the FDA. A Status Report on the effectiveness of the recall effort will be filed with the Atlanta District Office on a monthly basis until the recall is terminated.
Quantity in Commerce 700,000 units (of various product lines)
Distribution AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and Switzerland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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