Z-1175-2010

Thermoflect Product Line including items for adults and pediatrics

Name: Z-1175-2010 Thermoflect Product Line including items for adults and pediatrics
Creator: Encompass Group LLC
Published: 2009-12-23
License: https://open.fda.gov/license/

Encompass Group LLC / initiated 2009-12-23 / Terminated

FDA source

Encompass Group LLC began a recall of Thermoflect Product Line including items for adults and pediatrics on 2009-12-23. The reason FDA records is "The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1175-2010
Status: Terminated
Initiated: 2009-12-23
Posted: 2010-03-22
Terminated: 2010-10-27
Recalling firm: Encompass Group LLC
Product: Thermoflect Product Line including items for adults and pediatrics.
Product code: FME Gown, Examination
Reason for recall: The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.
FDA root cause: Other
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.
Product codes and lots: All Thermoflect items, all codes.

Product code FME

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)