Events

Recall of BUTTON REPLACEMENT GASTROSTOMY DEVICE

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
    54910
  • Event Risk Class
    I
  • Event Initiated Date
    2000-05-30
  • 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 partial occlusion could occur in the through-hole of the adapter that is inserted into the button device.

Device

BUTTON REPLACEMENT GASTROSTOMY DEVICE
  • Model / Serial
    Model Catalog: (Lot serial: ); Model Catalog: (Lot serial: VARIOUS PRODUCT AND LOT NO'S)
  • Product Description
    BUTTON REPLACEMENT GASTROSTOMY DEVICE
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.