Home / Recalls / Medical Devices
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maint
Recalled October 10, 2018 · FDA recall Z-0063-2019 · Cincinnati Sub-Zero Products LLC, a Gentherm
Hazard
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. · FDA Class II
Units
270 units
Sold at
US Nationwide Distribution
Description
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.
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.
Manufacturer(s)
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →