Events

Recall of MILEX PESSARY FITTING TRAY

According to Health Canada (via FOI), this recall involved a device in Canada 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
    22214
  • Event Risk Class
    III
  • Event Initiated Date
    2017-08-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Coopersugical has updated the instructions for use (ifu) for the milex pessaries. the change was made to clarify and update the patient cleaning section of previous versions of the instructions for use (ifu). coopersurgical therefore is sending an advisory notification to all affected customers and provide them with copies of the newly updated and approved instructions for use (ifu rev a - 2/12).

Device

MILEX PESSARY FITTING TRAY
  • Model / Serial
    Model Catalog: MXFIT-CA (Lot serial: > THAN 10 CONTACT MFR)
  • Product Description
    MILEX PESSARY FITTING TRAY
  • Manufacturer
    COOPERSURGICAL INC.

Manufacturer

COOPERSURGICAL INC.