BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A

    Recall: Z-1327-2025 · Reported March 19, 2025

    Enforcement

    Recall Number
    Z-1327-2025
    Event ID
    96240
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Spectrum Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    March 19, 2025
    Initiation Date
    January 16, 2025
    Classification Date
    March 13, 2025
    Address
    481 Munn Rd Ste 250, Fort Mill, SC, 29715-8408, United States

    Description

    Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A

    Reason

    Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

    Code Info

    Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511

    Distribution

    US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington.

    Quantity

    1487 unit