BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

    Recall: Z-0678-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0678-2020
    Event ID
    84377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2019
    Initiation Date
    December 3, 2019
    Classification Date
    December 12, 2019
    Termination Date
    September 18, 2020
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

    Reason

    A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

    Code Info

    UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680

    Distribution

    The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.

    Quantity

    11 distributed in the US