BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1424-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1424-2018
    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 BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

    Reason

    The integrity of the sterile packaging is potentially compromised.

    Code Info

    Product Code: a.) TJC3513 / LOT 0000848831, 0000851431, 0000854856; Product Code: b.) TJC4008 / LOT 0000841227, 0000846706, 0000848560, 0000849684, 0000853455; c.) TJC4011 / LOT 0000840667, 0000841228, 0000845874, 0000849717, 0000850937, 0000852121; d.) TJC6008 / LOT 0000841216, 0000848569, 0000851432, 0000852122, 0000853458; e.) TJC6011 / LOT 0000841124, 0000848571, 0000853975

    Distribution

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