BEUDAMED
    FDA Recall Terminated

    8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008

    Recall: Z-2411-2019 · Initiated August 1, 2019

    Recall

    Recall Number
    Z-2411-2019
    Event Number
    83537
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 1, 2019
    Terminated
    May 6, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008

    Reason

    Product Pouches may not be sealed properly and compromise the sterility of the device

    Action

    BD notified US consignees via FedEx August 1, 2019,and contacted via email. Sub recall requested and BD will notify customers. BD is requesting that customers destroy product at their location. The kit packer asked to return product. BD will mail additional communications to the kit customers. A business response form is included with the letter to assist direct consignees in responding to the field action. Questions contact BD Customer/Technical Support 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States.

    Distribution

    CA, IL Foreign: Taiwan

    Quantity

    700 units