BEUDAMED
    FDA Enforcement Class II Terminated

    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

    Recall: Z-1814-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1814-2015
    Event ID
    71329
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2015
    Initiation Date
    May 20, 2015
    Classification Date
    June 18, 2015
    Termination Date
    January 20, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

    Reason

    A diaphragm size 80 labeled box was incorrectly packaged with a size 85.

    Code Info

    Lot 153309

    Distribution

    AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND

    Quantity

    200 units