Hemotherm CE Dual Reservoir Cooler/Heater recalled over fire hazard

Recall date

December 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Coo…

Recall number

Z-0825-2019

FDA classification

Class II

Brand / firm

Cincinnati Sub-Zero Products LLC, a Gentherm Company

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The products were distributed to the following foreign countries: Columbia and Taiwan.

Why it was recalled

Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down 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 Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.