BEUDAMED
    FDA Enforcement Class I Terminated

    B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

    Recall: Z-2489-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2489-2019
    Event ID
    82966
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2019
    Initiation Date
    May 1, 2019
    Classification Date
    September 23, 2019
    Termination Date
    July 13, 2020
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    Description

    B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

    Reason

    Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).

    Code Info

    Lot Number 0061641410

    Distribution

    Distribution to US state of TX, and Canada.

    Quantity

    2580