BEUDAMED
    FDA Enforcement Class II Terminated

    Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)

    Recall: Z-2107-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2107-2020
    Event ID
    85389
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quest Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 3, 2020
    Initiation Date
    December 17, 2019
    Classification Date
    May 22, 2020
    Termination Date
    April 17, 2024
    Address
    1 Allentown Pkwy, N/A, Allen, TX, 75002-4206, United States

    Description

    Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)

    Reason

    Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.

    Code Info

    Lot Number: 059135

    Distribution

    US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None

    Quantity

    5 units