BEUDAMED
    FDA Enforcement Class I Terminated

    Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

    Recall: Z-1436-2013 · Reported June 19, 2013

    Enforcement

    Recall Number
    Z-1436-2013
    Event ID
    65248
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Endologix Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 19, 2013
    Initiation Date
    May 13, 2013
    Classification Date
    June 7, 2013
    Termination Date
    August 19, 2013
    Address
    11 Studebaker, N/A, Irvine, CA, 92618-2013, United States

    Description

    Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

    Reason

    Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.

    Code Info

    Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845

    Distribution

    Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.

    Quantity

    53