BEUDAMED
    FDA Enforcement Class II Terminated

    Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.

    Recall: Z-1689-2020 · Reported April 15, 2020

    Enforcement

    Recall Number
    Z-1689-2020
    Event ID
    85338
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2020
    Initiation Date
    March 17, 2020
    Classification Date
    April 9, 2020
    Termination Date
    July 15, 2024
    Address
    1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States

    Description

    Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.

    Reason

    Sterility compromised due to packaging pouches that may not be sealed properly

    Code Info

    Lot Numbers: 0001303256 and 0001303257

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, IL, NJ, NY, OH, TN, VA and countries of AUSTRALIA, INDIA, JAPAN, MALAYSIA, NEW ZEALAND, PHILIPPINES and SINGAPORE.

    Quantity

    8,170 units (US: 420 and OUS: 7,750)