BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 16, 2025

    Recall

    Recall Number
    Z-1327-2025
    Event Number
    96240
    Firm
    Spectrum Medical Inc
    FEI Number
    3006126428
    Product Code
    KFM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 16, 2025
    Posted
    March 13, 2025
    Address
    481 Munn Rd, Ste 250, Fort Mill, SC, 29715-8408

    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.

    Action

    On January 16, 2025, Spectrum Medical issued a Medical Device Recall notification to affected consignees via E-Mail. Spectrum Medical asked consignees to take the following actions: 1. Send back the Spectrum Medical Inc. a copy of the "Medical Device Recall Return Response" attached with all fields completed by emailing ht

    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