Events

Recall of CIRCON CABOT FALOPE-RING BAND TUBAL OCCLUSION SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OLYMPUS CANADA 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
    32993
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-30
  • 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
    On april 4 2014 a communication from the osta us distributor drew attention to the fact that part 000878-4 falope-ring dilator was inadvertently made available through the order system to customers and osta was shipping this item to our distributors in a non-sterile state. this item is normally only intended for use as a component provided with the falope ring band frb- 30 kits. the frb-30 kits including this component are sold sterile. this item is a dilator intended to assist placement of the falope band on the applicator. it contacts the sterile falope ring band as the band is loaded onto a reusable applicator and just prior to the band's implantation in the patient. as such it must be sterile in order to avoid the possibility of contaminating the falope ring band prior to use. no complaints related to these items have been received.

Device

CIRCON CABOT FALOPE-RING BAND TUBAL OCCLUSION SYSTEM
  • Model / Serial
    Model Catalog: 000878-4 (Lot serial: N/A)
  • Product Description
    GYRUS ACMI FALOPE-RING DILATOR
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.