BEUDAMED
    FDA Recall Terminated

    MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.

    Recall: Z-0253-2016 · Initiated September 14, 2015

    Recall

    Recall Number
    Z-0253-2016
    Event Number
    72204
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HHW
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 14, 2015
    Posted
    November 10, 2015
    Terminated
    January 8, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.

    Reason

    The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification.

    Action

    Cooper Surgical sent an Urgent Medical Device Recall letter dated September 14, 2015 via FedEx with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Customers were asked to discontinue use of the affected products and complete the Acknowledgement and Receipt form for a free replacement. For questions contact Product Surveillance at 203.601.5200 ext. 3300.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AR, CA, CO, GA, IL, KY, LA, MA, MD, MI, MT, NC, NY, OH, OK, PA, RI, SD, VA, WA, WI,WV and in the countries of FRANCE and VIETNAM.

    Quantity

    144 units