BEUDAMED
    FDA Enforcement Class III Terminated

    CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues

    Recall: Z-0207-2015 · Reported November 19, 2014

    Enforcement

    Recall Number
    Z-0207-2015
    Event ID
    69500
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2014
    Initiation Date
    September 30, 2014
    Classification Date
    November 13, 2014
    Termination Date
    May 28, 2015
    Address
    75 Vista Pl, Trumbull, CT, 06611-3934, United States

    Description

    CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues

    Reason

    Incorrect expiration date printed on the MILEX PESSARY KIT packaging

    Code Info

    Lot Number: 146351

    Distribution

    US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL

    Quantity

    17 units