BEUDAMED
    FDA Enforcement Class II Terminated

    WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

    Recall: Z-1703-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1703-2016
    Event ID
    74171
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    April 26, 2016
    Classification Date
    May 20, 2016
    Termination Date
    March 10, 2017
    Address
    901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States

    Description

    WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

    Reason

    Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

    Code Info

    Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.

    Distribution

    Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.

    Quantity

    5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]