BEUDAMED
    FDA Enforcement Class II Terminated

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    Recall: Z-2082-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2082-2015
    Event ID
    70783
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Owen Mumford USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    December 11, 2014
    Classification Date
    July 15, 2015
    Termination Date
    July 11, 2017
    Address
    1755 W Oak Commons Ct, N/A, Marietta, GA, 30062-2280, United States

    Description

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    Reason

    The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.

    Code Info

    Lot 7JH, UPC Code 384703800014

    Distribution

    Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.

    Quantity

    225 units