Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Class I - DangerousWhat Should You Do?
- Check if you have this product: All units in service life Serial Numbers: 092-10011CE tot 212-11499CE
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Gentherm Medical, LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Product Codes/Lot Numbers:
All units in service life Serial Numbers: 092-10011CE tot 212-11499CE
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2092-2021
Related Recalls
Class I - Dangerous
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.