BEUDAMED
    FDA Enforcement Class II Ongoing

    Autoject EI, REF AJ1310

    Recall: Z-0263-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0263-2020
    Event ID
    83465
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Owen Mumford USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2019
    Initiation Date
    July 17, 2019
    Classification Date
    November 1, 2019
    Address
    1755 W Oak Commons Ct, N/A, Marietta, GA, 30062-2280, United States

    Description

    Autoject EI, REF AJ1310

    Reason

    There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107

    Code Info

    Lot/Unit Number: V14

    Distribution

    FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA

    Quantity

    1510 units