BEUDAMED
    FDA Enforcement Class II 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 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2092-2021
    Event ID
    88187
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gentherm Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 28, 2021
    Initiation Date
    June 17, 2021
    Classification Date
    July 19, 2021
    Termination Date
    March 1, 2023
    Address
    12011 Mosteller Rd Fl 3, N/A, Blue Ash, OH, 45241-1528, United States

    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.

    Code Info

    All units in service life Serial Numbers: 092-10011CE tot 212-11499CE

    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)