Events

Recall of PONSKY NON-BALLOON REPLACEMENT GASTROSTOMY TUBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD 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
    97716
  • Event Risk Class
    II
  • Event Initiated Date
    2008-05-16
  • 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
    Dome develops a tear during device stretch & distention with an obturator or the obturator may slip out of the pocket during placement.

Device

PONSKY NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
  • Model / Serial
    Model Catalog: 000630 (Lot serial: HURJ0589 HURJ1533 HURE3333); Model Catalog: 000631 (Lot serial: HURJ0589 HURJ1533 HURE3333); Model Catalog: 000630 (Lot serial: HURG1431 HURJ0568); Model Catalog: 000631 (Lot serial: HURG1431 HURJ0568)
  • Product Description
    PONSKY NON-BALLOON GASTROSTOMY TUBE
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.