BEUDAMED
    FDA Enforcement Class II Terminated

    3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573

    Recall: Z-2007-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2007-2019
    Event ID
    82138
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    February 1, 2019
    Classification Date
    July 22, 2019
    Termination Date
    June 11, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573

    Reason

    The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.

    Code Info

    Lot Number 8303571

    Distribution

    The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.

    Quantity

    460,800