Events

Recall of QUANTUM TTC BILIARY BALLOON DILATOR

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
    49258
  • Event Risk Class
    II
  • Event Initiated Date
    2007-01-31
  • 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
    A secondary graphic package label on the product showed the wrong size (6mm/18fr instead of the correct 10mm/30fr). the main package label is correct.

Device

QUANTUM TTC BILIARY BALLOON DILATOR
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    quantum biliary dilation balloon
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.