Reported Feb 20, 2019 · Terminated
Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir…
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 CE Dual Reservoir Cooler/Heater, Model No. 400CE
- Product UsageThe 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
- Lot codes and dates
- Serial numbers 151-10283CE through 171-10721CE
- Amount recalled
- 396
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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