FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2092-2021
- Recalling firm
- Gentherm Medical, LLC
- Product
- Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
- Status
- Terminated
- Initiated
- 2021-06-17
- Posted
- not on file
- Terminated
- 2023-03-01
- 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) Complete and return the customer response form via email to FA2021-004@gentherm.com.
- 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
- Lot, serial or model codes
- All units in service life Serial Numbers: 092-10011CE tot 212-11499CE
- 510(k) numbers
- ["K122813"]
- PMA numbers
- not on file
- Product code
- DWC
- Firm FEI
- 1516825
- Firm city
- Blue Ash
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28