BEUDAMED
    FDA Recall Open, Classified

    Autoject EI, REF AJ1310

    Recall: Z-0263-2020 · Initiated July 17, 2019

    Recall

    Recall Number
    Z-0263-2020
    Event Number
    83465
    Firm
    Owen Mumford USA, Inc.
    FEI Number
    1000219614
    Product Code
    KZH
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    July 17, 2019
    Address
    1755 W Oak Commons Ct, Marietta, GA, 30062-2280

    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

    Action

    The firm initiated the recall by letter on 07/17/2019. The consignee was directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers.

    Distribution

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

    Quantity

    1510 units