BEUDAMED
    FDA Recall Terminated

    CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient

    Recall: Z-3269-2011 · Initiated August 11, 2011

    Recall

    Recall Number
    Z-3269-2011
    Event Number
    59664
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    ODX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 11, 2011
    Posted
    September 20, 2011
    Terminated
    August 24, 2016
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient

    Reason

    Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions

    Action

    Fresenius Medical Care sent out an "Urgent" recall notice dated August 11, 2011 to all affected customers . The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius. For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.

    Distribution

    Nationwide Distribution.

    Quantity

    118 cases