BEUDAMED
    FDA Recall Terminated

    BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.

    Recall: Z-1577-2013 · Initiated May 1, 2013

    Recall

    Recall Number
    Z-1577-2013
    Event Number
    65243
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    MEG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 1, 2013
    Posted
    June 21, 2013
    Terminated
    September 25, 2013
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.

    Reason

    There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.

    Action

    Direct consignees were contacted by phone and email on 05/01/2013 and instructed to return the affected product. End users were mailed "Urgent: Product Recall" letters/Response Forms dated 05/01/2013. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product.

    Distribution

    Worldwide Distribution including US Nationwide and the countries of Canada and Suriname.

    Quantity

    1,326,000 units