BEUDAMED
    FDA Enforcement Class II Terminated

    Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

    Recall: Z-0691-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0691-2017
    Event ID
    75291
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2016
    Initiation Date
    July 29, 2016
    Classification Date
    December 1, 2016
    Termination Date
    March 6, 2018
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    Description

    Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

    Reason

    Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

    Code Info

    Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198

    Distribution

    Nationwide Distribution to GA, IL, and FL

    Quantity

    15,950 units