BEUDAMED
    FDA Enforcement Class II Terminated

    "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

    Recall: Z-0814-2019 · Reported February 13, 2019

    Enforcement

    Recall Number
    Z-0814-2019
    Event ID
    81968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiotech (Manan Medical Products, Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2019
    Initiation Date
    December 18, 2018
    Classification Date
    February 7, 2019
    Termination Date
    August 23, 2020
    Address
    241 W Palatine Rd, Wheeling, IL, 60090-5824, United States

    Description

    "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

    Reason

    Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

    Code Info

    Model Number IMKBMN-11R-10-X, Lot Numbers LJUE, LEAC, LFKX; Model Number IMKBMN-11R-10, Lot Numbers LK0J, LEHU

    Distribution

    Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

    Quantity

    9,900 units