BEUDAMED
    FDA Recall Terminated

    BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    Recall: Z-2753-2017 · Initiated September 16, 2016

    Recall

    Recall Number
    Z-2753-2017
    Event Number
    77513
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMF
    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 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    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

    1,528,000 units