BEUDAMED
    FDA Enforcement Class II Ongoing

    CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

    Recall: Z-0035-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0035-2022
    Event ID
    88622
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CardioQuip, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    October 13, 2021
    Initiation Date
    May 12, 2021
    Classification Date
    October 6, 2021
    Address
    8422 Calibration Ct, College Station, TX, 77845-5328, United States

    Description

    CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

    Reason

    Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

    Code Info

    All Serial numbers

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.

    Quantity

    1478 units