Recall Z-2092-2021 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Gentherm Medical, LLC
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
| Date | Jun 17, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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) Complet |
| 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, Turk |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM Cincinnati Sub-Zero Products, Inc., Dec 18, 2012 |