Reported Jul 28, 2021 · Terminated
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during…
Gentherm Medical, LLC
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: Gentherm Medical, LLC · 12011 Mosteller Rd Fl 3 · Blue Ash, OH · 45241-1528
Is this the product you have?
- Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
- Lot codes and dates
- All
- units in service life Serial Numbers092-10011CE tot 212-11499CE
- Amount recalled
- 1448 devices (1010 US; 438 OUS)
Where it was sold
- Nationwide
- PR
Why it was recalled
There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.
This product could cause temporary or reversible health problems — stop using it.
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