BEUDAMED
    FDA Recall Terminated

    J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

    Recall: Z-0815-2019 · Initiated December 18, 2018

    Recall

    Recall Number
    Z-0815-2019
    Event Number
    81968
    Firm
    Angiotech (Manan Medical Products, Inc.)
    FEI Number
    1417485
    Product Code
    DWO
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    December 18, 2018
    Terminated
    August 23, 2020
    Address
    241 W Palatine Rd, Wheeling, IL, 60090-5824

    Description

    J Type Bone Marrow Needle 13ga 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

    Action

    Argon Medical Devices notified customers on about 12/18/2018 via "Urgent - Field Safety Notice" letter. Instructions included complete and return the response form a quickly as possible, return all affected product to their Argon Wheeling facility, and to provide the recall notification to all who need to be aware within the organization as well as any organization where the affected product was distributed.

    Distribution

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

    Quantity

    1,260 units