BEUDAMED
    FDA Recall Terminated

    BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062

    Recall: Z-2747-2017 · Initiated September 16, 2016

    Recall

    Recall Number
    Z-2747-2017
    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 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062

    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

    22,400 units