medical Class II Updated 2018-10-10

Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hem

Recalled Product

Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ 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

Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI 10613031860221
View official government recall

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