BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0411-2018 · Initiated December 21, 2017

    Recall

    Recall Number
    Z-0411-2018
    Event Number
    78835
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FLD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 21, 2017
    Terminated
    August 4, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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.

    Action

    The firm initiated their recall on 12/21/2017 by letter. The recall notice stated the following actions to be taken by the customers: "1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual MARS Treatment Kit box. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270- 5457 or scanning and e-mailing it to [email protected], even if you do not have any inventory."

    Distribution

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

    Quantity

    186 units