BEUDAMED
    FDA Recall 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 · Initiated September 30, 2014

    Recall

    Recall Number
    Z-0207-2015
    Event Number
    69500
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HHW
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    September 30, 2014
    Posted
    November 13, 2014
    Terminated
    May 28, 2015
    Address
    75 Vista Pl, Trumbull, CT, 06611-3934

    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

    Action

    CooperSurgical notified customers a Recall Notification dated September 29, 2014, via UPS . The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical's will replace any of the affected and provided further instruction on the disposition of the product at the time of replacement. If you have any further questions, contact 203.601.5200. .

    Distribution

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

    Quantity

    17 units