BEUDAMED
    FDA Recall Terminated

    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

    Recall: Z-1814-2015 · Initiated May 20, 2015

    Recall

    Recall Number
    Z-1814-2015
    Event Number
    71329
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HDW
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 20, 2015
    Posted
    June 18, 2015
    Terminated
    January 20, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

    Reason

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

    Action

    CooperSurgical notified consignees by letter on 5/18/15 via Fedex with confirmed delivery receipt.. Accounts requested to discontinue use and complete the attached Acknowledgement and Receipt Form for replacement. CooperSurgical provided further instruction on the disposition of the product at the time of replacement If you have any further questions please feel free to contact 203.601.5200. .

    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