Reported Oct 10, 2018 · Terminated
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain,…
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cincinnati Sub-Zero Products LLC, a Gentherm Company · 12011 Mosteller Rd · Cincinnati, OH · 45241-1528
Is this the product you have?
- 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.
- Lot codes and dates
- UDI 10613031860221
- Amount recalled
- 270 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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