Recall Z-2092-2021— Gentherm Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Gentherm Medical, LLC, initiated 2021-06-17, terminated 2023-03-01. It names one FDA 510(k) clearance: K122813. Product: Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures. Reason: 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..
- Recalling firm
- Gentherm Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-17
- Terminated
- 2023-03-01
- Firm location
- Blue Ash, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.