Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hemotherm CE Dual Reservoir Cooler/Heater Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company Due to Evidence supports that when customers performed a fuse...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cincinnati Sub-Zero Products LLC, a Gentherm Company directly.
Affected Products
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.
Quantity: 396
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cincinnati Sub-Zero Products LLC, a Gentherm Company
Cincinnati Sub-Zero Products LLC, a Gentherm Company has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report