Recall Z-1175-2010 ยท FME Gown, Examination
Encompass Group LLC
Thermoflect Product Line including items for adults and pediatrics.
| Date | Mar 22, 2010 (initiated Dec 23, 2009) |
| Status | Terminated |
| Reason | The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment. |
| 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 outerm |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.