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
    57831
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-02
  • 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
    Due to an anomaly in the packaging process it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. the breach may or may not be easily seen.

Device

CIRCON CABOT FALOPE-RING BAND TUBAL OCCLUSION SYSTEM
  • Model / Serial
    Model Catalog: 006889-901 (Lot serial: All lots); Model Catalog: 005280-901 (Lot serial: All lots)
  • Product Description
    Disposable Falope Ring Band Applicator Kit
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.