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, maintain,…

Recall date

September 4, 2018

Source

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

Recall number

Z-0063-2019

FDA classification

Class II

Brand / firm

Cincinnati Sub-Zero Products LLC, a Gentherm Company

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

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 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.