Events

Recall of Device Recall CooperSurgical MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

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
    71329
  • Event Risk Class
    Class 2
  • Event Number
    Z-1814-2015
  • Event Initiated Date
    2015-05-20
  • Event Date Posted
    2015-06-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137315
  • 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
    Diaphragm, contraceptive (and accessories) - Product Code HDW
  • Reason
    A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
  • Action
    CooperSurgical notified consignees by letter on 5/18/15 via Fedex with confirmed delivery receipt.. Accounts requested to discontinue use and complete the attached Acknowledgement and Receipt Form for replacement. CooperSurgical provided further instruction on the disposition of the product at the time of replacement If you have any further questions please feel free to contact 203.601.5200. .

Device

Device Recall CooperSurgical MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
  • Model / Serial
    Lot 153309
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
  • Product Description
    MILEX OMNIFLEX DIAPHRAGM SIZE 80 || Model: MXWF80
  • 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