BEUDAMED
    FDA Enforcement Class II Terminated

    JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;

    Recall: Z-1422-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1422-2018
    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 NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;

    Reason

    The integrity of the sterile packaging is potentially compromised.

    Code Info

    Product Code: SN1015X / LOT 0000840334 ; Product Code: SN1016X / LOT 0000848028 ; Product Code: SN1017X / LOT 0000848018 ; Product Code SN7016X / LOT 0000848017

    Distribution

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

    Quantity

    790 units