BEUDAMED
    FDA Enforcement Class III Terminated

    Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

    Recall: Z-1012-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-1012-2013
    Event ID
    64531
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cooper Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    February 26, 2013
    Classification Date
    March 27, 2013
    Termination Date
    March 4, 2014
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

    Reason

    Pessary mislabeled outer package may not reflect the size of the product contained in the package

    Code Info

    Lot Number:121784

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

    Quantity

    20 units