BEUDAMED
    FDA Enforcement Class II Terminated

    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.

    Recall: Z-1366-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1366-2015
    Event ID
    70665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Owen Mumford USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    November 24, 2014
    Classification Date
    April 2, 2015
    Termination Date
    July 31, 2017
    Address
    1755 W Oak Commons Ct, N/A, Marietta, GA, 30062-2280, United States

    Description

    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.

    Reason

    The syringe carrier is missing components: a damper and spring.

    Code Info

    Lot No. 5LW

    Distribution

    US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.

    Quantity

    3,100