BEUDAMED
    FDA Recall Terminated

    BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination

    Recall: Z-2748-2017 · Initiated September 16, 2016

    Recall

    Recall Number
    Z-2748-2017
    Event Number
    77513
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 16, 2016
    Terminated
    March 20, 2018
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination

    Reason

    BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

    Action

    BD sent recall letter/return response form on 9/16/2016.

    Distribution

    Nationwide Distribution

    Quantity

    29,500 units