Events

Recall of TRI-EX TRIPLE LUMEN EXTRACTION BALLOON

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (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
    134843
  • Event Risk Class
    III
  • Event Initiated Date
    2014-07-17
  • 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
    Some units of the recalled device may not fit down a 2.8mm endoscope despite being labeled as compatible with endoscope channels of that size. the issue was uncovered during a customer complaint investigation.

Device

TRI-EX TRIPLE LUMEN EXTRACTION BALLOON
  • Model / Serial
    Model Catalog: TXR-ME (Lot serial: W3342312)
  • Product Description
    Tri-Ex Extraction Balloon with Multiple Sizing
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.