BEUDAMED
    FDA Enforcement Class II Terminated

    AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.

    Recall: Z-1497-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1497-2016
    Event ID
    73339
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 20, 2016
    Initiation Date
    January 26, 2016
    Classification Date
    April 14, 2016
    Termination Date
    October 27, 2016
    Address
    8000 Katherine Blvd, N/A, Brecksville, OH, 44141-4202, United States

    Description

    AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.

    Reason

    The firm received complaints that the product is shorter in length than indicated on the label.

    Code Info

    Model #GJ-1415-45, Lot # 15104750, Exp Date: 2018/09

    Distribution

    Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.

    Quantity

    20 units