Events

Recall of Device Recall Cooper Surgical Incontinence Ring Flexible Pessary 4

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cooper Surgical, 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
    64531
  • Event Risk Class
    Class 3
  • Event Number
    Z-1004-2013
  • Event Initiated Date
    2013-02-26
  • Event Date Posted
    2013-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116408
  • 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
    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.

Device

Device Recall Cooper Surgical Incontinence Ring Flexible Pessary 4
  • Model / Serial
    Lot Number:117301
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
  • Product Description
    Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex || Part Number: MXPCON04 || 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.
  • Manufacturer
    Cooper Surgical, Inc.

Manufacturer

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