BEUDAMED
    FDA Enforcement Class II Terminated

    10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216

    Recall: Z-2548-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2548-2021
    Event ID
    88531
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    August 10, 2021
    Classification Date
    September 24, 2021
    Termination Date
    September 16, 2024
    Address
    901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States

    Description

    10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216

    Reason

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Code Info

    Lot Code: 0061760493 0061763906 0061764288 0061765128 0061771281 DI: 04046964182273

    Distribution

    Worldwide distribution - US Nationwide distribution and the country of Canada.

    Quantity

    55,584 units