BEUDAMED
    FDA Enforcement Class II Terminated

    BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122

    Recall: Z-0508-2021 · Reported December 9, 2020

    Enforcement

    Recall Number
    Z-0508-2021
    Event ID
    86679
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2020
    Initiation Date
    October 23, 2020
    Classification Date
    November 27, 2020
    Termination Date
    September 8, 2023
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122

    Reason

    Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.

    Code Info

    Batch Number: 9352052 Exp. Date: 20241231

    Distribution

    Nationwide

    Quantity

    2,881,200 units