Medical device recalls Moderate risk

Cincinnati Sub-Zero Products Inc recalls Hemotherm CE, model 400CE, Heater-Cooling Device

Recall date
March 9, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1825-2017
FDA classification
Class II
Brand / firm
Cincinnati Sub-Zero Products Inc
Sold / distributed
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…

Why it was recalled

Improperly rated fuses were used in the manufacture of the device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hemotherm CE, model 400CE, Heater-Cooling Device

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