Events

Recall of MILEX PESSARY KIT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CooperSurgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72204
  • Event Risk Class
    Class 3
  • Event Number
    Z-0253-2016
  • Event Initiated Date
    2015-09-14
  • Event Date Posted
    2015-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140171
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pessary, vaginal - Product Code HHW
  • 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.

Device

MILEX PESSARY KIT
  • Model / Serial
    MXPES00: Lot139411; 157299; 180533 MXKPES00: Lot 125143; 142853 MXKPREG03: Lot 153096 MXKPGSK07: Lot 157364; 160432
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Manufacturer Address
    CooperSurgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA