BEUDAMED
    FDA Enforcement Class II Terminated

    MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541

    Recall: Z-0411-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0411-2018
    Event ID
    78835
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    December 21, 2017
    Classification Date
    January 24, 2018
    Termination Date
    August 4, 2020
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541

    Reason

    Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.

    Code Info

    UDI: 37332414107728; Lot Numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767

    Distribution

    US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.

    Quantity

    186 units