FDA-Device2018-10-10Class II
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.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
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.
Sold states
US Nationwide Distribution
Affected count
270 units
Manufactured in
12011 Mosteller Rd, Cincinnati, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2019Don't want to check this manually?
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