BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0565-2024 · Initiated October 24, 2023

    Recall

    Recall Number
    Z-0565-2024
    Event Number
    93446
    Firm
    CardioQuip, LLC
    FEI Number
    3007899424
    Product Code
    DWC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 24, 2023
    Posted
    December 15, 2023
    Address
    8422 Calibration Ct, College Station, TX, 77845-5328

    Description

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

    Reason

    There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

    Action

    On October 24, 2023, CardioQuip issued a "Urgent: Medical Device Correction/Removal" notification via USPS to all affected consignees. CardioQuip ask consignees to take the following actions: 1. CardioQuip recommends that you remove your potentially contaminated MCH device from service immediately. 2. CardioQuip Customer Service will contact you by November 3, 2023 to provide your facility with a loaner device and to schedule an IWPR procedure for your MCH device. 3. Please complete and return the Receipt of Communication/Response Form attached to this letter to CardioQuip as soon as possible. 4. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program:

    Distribution

    US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None

    Quantity

    4 units