FDA-Device2017-04-26Class II
Hemotherm CE, model 400CE, Heater-Cooling Device
Cincinnati Sub-Zero Products Inc
Hazard
Improperly rated fuses were used in the manufacture of the device.
Sold states
Worldwide distribution. The recalled product was distributed to the following states: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The recalled product was distributed to the following countries: Mexico, Taiwan. There are no Canada accounts for this recall. There is one (1) Mexico account for this recall: Koolfer S.A. DE C.V., San Isidro 168, Col. Pedregal De Santa Ursula Coapa, Del. Coyoacan, CP. Mexico D. F. 04600. There is one (1) government account for this recall: WRNMMC -PAA, 8965 Brown Dr, Bethesda, MD 20889.
Affected count
390 devices
Manufactured in
12011 Mosteller Rd, N/A, Cincinnati, OH, United States
Products
Hemotherm CE, model 400CE, Heater-Cooling Device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2017Don't want to check this manually?
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