BEUDAMED
    FDA Enforcement Class II Ongoing

    CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.

    Recall: Z-0069-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0069-2022
    Event ID
    88621
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CardioQuip, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    June 24, 2021
    Classification Date
    October 7, 2021
    Address
    8422 Calibration Ct, College Station, TX, 77845-5328, United States

    Description

    CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.

    Reason

    There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.

    Code Info

    All Serial Numbers

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of TX, PA, FL, CA, HI, SC, OH, AK, NY, IL, AR, WI, MI, AL, KS, NJ, GA, AZ, KY, MS, TN, LA, DE, MA, VA, CO, NE, NC, NH, ME, WV, PA, MO, MN, IN, CT, NH, NV, UT and the country of Venezuela.

    Quantity

    1380 units