BEUDAMED
    FDA Enforcement Class II Terminated

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    Recall: Z-2175-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2175-2013
    Event ID
    64150
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2013
    Initiation Date
    December 5, 2012
    Classification Date
    September 10, 2013
    Termination Date
    October 24, 2014
    Address
    1601 Wallace Dr Ste 150, N/A, Carrollton, TX, 75006-6690, United States

    Description

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    Reason

    B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on

    Code Info

    Models 620-100 and 620-200; multiple serial numbers

    Distribution

    Worldwide Disribution: USA (nationwide) and country of: Canada.

    Quantity

    14,161