BEUDAMED
    FDA Recall 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 · Initiated February 26, 2013

    Recall

    Recall Number
    Z-1012-2013
    Event Number
    64531
    Firm
    Cooper Surgical, Inc.
    FEI Number
    1216677
    Product Code
    HHW
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 26, 2013
    Posted
    March 27, 2013
    Terminated
    March 4, 2014
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    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

    Action

    Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974. For questions regarding this recall call 203-601-9825.

    Distribution

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

    Quantity

    20 units