BEUDAMED
    FDA Enforcement Class II Terminated

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    Recall: Z-0207-2018 · Reported December 13, 2017

    Enforcement

    Recall Number
    Z-0207-2018
    Event ID
    77639
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2017
    Initiation Date
    May 31, 2017
    Classification Date
    December 7, 2017
    Termination Date
    June 28, 2018
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    Reason

    Hub damage resulting in breakage and/or leakage during use.

    Code Info

    Lot Number: 6152995 Expiration Date: 31-Jul-21

    Distribution

    Nationwide Distribution

    Quantity

    2,598,000 units