BEUDAMED
    FDA Recall Terminated

    Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator

    Recall: Z-1373-2016 · Initiated February 23, 2016

    Recall

    Recall Number
    Z-1373-2016
    Event Number
    73390
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    KFM
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    February 23, 2016
    Terminated
    September 25, 2019
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator

    Reason

    Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

    Action

    The firm, Maquet Inc., sent an "URGENT MEDICAL DEVICE RECALL" Letter/Response Form dated 2/23/2016 via Fed Ex to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the list to determine if you have the affected products; monitor patients for signs; monitor and treat signs according to your protocols and clinical judgments; support shock symptoms and maintain circulatory and hemodynamics per your facility's protocol and care guidelines, and complete and and return the enclosed Response Form by email to: [email protected] or fax to: 1-973-629-1518 within three (3) business days. For any questions, please contact your Maquet sales and representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2) Monday through Friday, between the hours of 8:00am and 6:00pm EST.

    Distribution

    US Nationwide Distribution.

    Quantity

    72,000 units in total