BEUDAMED
    FDA Enforcement Class II Terminated

    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

    Recall: Z-1425-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1425-2018
    Event ID
    76620
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    February 23, 2017
    Classification Date
    April 18, 2018
    Termination Date
    July 9, 2019
    Address
    75 N Fairway Dr, Vernon Hills, IL, 60061-1845, United States

    Description

    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

    Reason

    The integrity of the sterile packaging is potentially compromised.

    Code Info

    Product Code: a.) TJM3513 / LOT 0000836582, 0000838949, 0000843968, 0000849685, 0000852933; b.) TJM4008 / LOT 0000841349, 0000841348, 0000843961, 0000849132, 0000852123, 0000853877; c.) TJM4011 / LOT 0000836575, 0000838950, 0000840195, 0000843075, 0000843076, 0000846708, 0000852932, 0000853878, 0000854861, 0000854983; d.) TJM6008 / LOT 0000842725, 0000853971; e.) TJM6011 / LOT 0000843077, 0000849713, 0000854659

    Distribution

    Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

    Quantity

    14,200 units