medical Class II Updated 2019-02-20

Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial numbers 151-10283CE through 171-10721CE
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →