Recall Z-2092-2021
Gentherm Medical, LLC · initiated June 17, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Codes / lots: All units in service life Serial Numbers: 092-10011CE tot 212-11499CE
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.
FDA-determined cause: Process control
Action taken
On 6/17/2021, Gentherm issued Urgent Medical Device Recall notices and response forms to customers via courier service. Instructions to Customers: 1) Immediately examine your inventory, access updated manuals and ensure obsolete manuals are removed from service. 2) Updated manuals may be accessed via www.gentherm.com or physicial copies may be requested from Gentherm Medical, LLC at 1-888-437-5608. 3) Ensure that all users are informed of the contents of this letter. 4) If you have further distributed this product, please provide those accounts with a copy of this notice. 5) Complete and return the customer response form via email to FA2021-004@gentherm.com.
Details
- Recall number
- Z-2092-2021
- Initiated
- June 17, 2021
- Terminated
- March 1, 2023
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 1448 devices (1010 US; 438 OUS)
- Distribution
- Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey, UAE
- Recalling firm
- Gentherm Medical, LLC, Blue Ash, OH