BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0069-2022 · Initiated June 24, 2021

    Recall

    Recall Number
    Z-0069-2022
    Event Number
    88621
    Firm
    CardioQuip, LLC
    FEI Number
    3007899424
    Product Code
    DWC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 24, 2021
    Address
    8422 Calibration Ct, College Station, TX, 77845-5328

    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.

    Action

    On 7/30/21, CardioQuip, issued a "Urgent Medical Device Correction" notification to affected consignees. The notification was provided online through CardioQuip's website and mailed letters. In addition to notifying consignees about the recall, the firm requested consignees take the following actions to reduce the risk of patient infection: 1. The optional Airflow Redirection Hood (MCH-10ARH) may be installed onto the Refrigeration Module(MCH-10RMS) as a potential mitigant to aerosolization. This device is attached overtop the Refrigeration Module and directs exhaust downwards, thereby redirecting potential aerosols downwards and away from the surgical field. Refer to the MCH Operator/Service Manual R3 2021 for installation instructions. Contact your local CardioQuip representative for assistance purchasing the optional Airflow Redirection Hood for your Refrigeration Module. 2.Ensure all modules and accessories, including the Airflow Redirection Hood and Refrigeration Module,are cleaned and disinfected at the same time as the MCH unit according to the Maintenance section on pg. 47 of the MCH Operator/Service Manual R3 2021. 3.Do NOT move modules or accessories between cooler-heater devices to prevent possible cross-contamination. 4.Please forward this notice to all device users and other parties within and outside your organizationthat need to be aware of this correction. 5. CardioQuip continues to develop a more comprehensive understanding of these risks and determine further action. If you have any questions or concerns regarding the Refrigeration Module (MCH-10RMS), optional Airflow Redirection Hood (MCH-10ARH), or proper device maintenance procedures, please contact CardioQuip via phone or email at: CardioQuip Customer Service: +1 (979) 691-0202 Monday Friday 8 A.M. 5 P.M. CT [email protected] 6. Receipt and understanding of the corrective action outlined in this letter is required from each CardioQuip customer. Please complete and return the e

    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