Events

Recall of Device Recall Milex Arcing Diaphragm

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
    73329
  • Event Risk Class
    Class 2
  • Event Number
    Z-1054-2016
  • Event Initiated Date
    2016-02-16
  • Event Date Posted
    2016-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143902
  • 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
    The products have been identified to contain an incorrect size diaphragm.
  • Action
    Cooper Surgical sent an "Urgent - Medical Device Recall" letter dated February 16, 2016, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt form for replacement. For further questions, please call (203) 601-9818.

Device

Device Recall Milex Arcing Diaphragm

Manufacturer

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