BEUDAMED
    FDA Recall Terminated

    Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets

    Recall: Z-0837-2011 · Initiated August 24, 2010

    Recall

    Recall Number
    Z-0837-2011
    Event Number
    57099
    Firm
    B Braun Medical, Inc
    FEI Number
    1641965
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 24, 2010
    Posted
    January 10, 2011
    Terminated
    May 29, 2014
    Address
    1601 Wallace Dr, Ste 150, Carrollton, TX, 75006-6690

    Description

    Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets

    Reason

    Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operation.

    Action

    B. Braun Medical Inc. notified consignee by letter on August 24, 2010.

    Distribution

    Virginia and New York

    Quantity

    2,107 Pumps (582 Pumps to Winchester)