BEUDAMED
    FDA Recall Terminated

    Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures

    Recall: Z-2092-2021 · Initiated June 17, 2021

    Recall

    Recall Number
    Z-2092-2021
    Event Number
    88187
    Firm
    Gentherm Medical, LLC
    FEI Number
    1516825
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 17, 2021
    Terminated
    March 1, 2023
    Address
    12011 Mosteller Rd, Fl 3, Blue Ash, OH, 45241-1528

    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

    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.

    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 [email protected].

    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

    Quantity

    1448 devices (1010 US; 438 OUS)