Events

Recall of CIRCON CABOT PLEATMAN SAC TISSUE REMOVAL 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
    32290
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-13
  • 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
    Trays used to package the pleatman sac product had cracks and/or dimples on them. further investigation revealed the dimples could form cracks when the tray is manipulated. this could lead to a breach in the sterile barrier which could compromise sterility of the product.

Device

CIRCON CABOT PLEATMAN SAC TISSUE REMOVAL SYSTEM
  • Model / Serial
    Model Catalog: 004942-903 (Lot serial: Lot Number: 186540FC)
  • Product Description
    PLEATMAN SAC TISSUE REMOVAL SYSTEM
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.