BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725

    Recall: Z-1244-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1244-2023
    Event ID
    91495
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    February 1, 2023
    Classification Date
    March 10, 2023
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725

    Reason

    Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

    Code Info

    GTIN: N/A Lot Number: 2010670, Exp. Date:2031581 Lot Number: 2052365, Exp. Date:20270531

    Distribution

    Worldwide distribution - US Nationwide and the countries of Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Mexico, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, Canada.

    Quantity

    1,472,400 units