BEUDAMED
    FDA Recall Open, Classified

    CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A

    Recall: Z-0438-2024 · Initiated October 19, 2023

    Recall

    Recall Number
    Z-0438-2024
    Event Number
    93347
    Firm
    CardioQuip, LLC
    FEI Number
    3007899424
    Product Code
    DWC
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 19, 2023
    Posted
    December 1, 2023
    Address
    8422 Calibration Ct, College Station, TX, 77845-5328

    Description

    CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A

    Reason

    There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

    Action

    On 10/19/23, CardioQuip issued a "Urgent: Medical Device Correction" notification to all affected consignees. This notification was an update to the firm's May 22, 2023 communication. CardioQuip ask consignees to take the following actions: 1. Prime the MCH-1000(i) and MCH-1000(m) prior to each use. 2.Never operate the device dry (see communication for further details). 3. Design Changes to be implemented (see communication for further details). A. Relocation of the water Level Sensor (see communication for further details). B. Software Update (see communication for further details). 4. Please fill out and submit the receipt of understanding of the contents of this letter to CardioQuip within 5 business days or receipt. 5. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program: Phone: +1 (800) FDA-1088 Web: www.fda.gov/medwatch/report.htm

    Distribution

    US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA

    Quantity

    150 units