BEUDAMED
    FDA Enforcement Class II Terminated

    "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.

    Recall: Z-2189-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2189-2013
    Event ID
    65984
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2013
    Initiation Date
    July 31, 2013
    Classification Date
    September 11, 2013
    Termination Date
    April 14, 2017
    Address
    1 Edwards Way, N/A, Irvine, CA, 92614-5688, United States

    Description

    "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.

    Reason

    The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.

    Code Info

    595531157

    Distribution

    Nationwide Distribution including MO and MI.

    Quantity

    35 units