Events

Recall of 2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distributed between June 2013 to June 2015

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard Australia Pty Ltd.

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
    RC-2015-RN-01254-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01254-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Bmd has identified that the instructions for use (ifu) included with the affected products provide the incorrect inflation volume. the inflation volume provided on the catheter’s valve cap does state the correct inflation volume. the ifu contains a chart entitled recommended inflation volumes with incorrect volumes. the inflation volume provided on the catheters valve cap does state the correct inflation volume.If the user follows the ifu and under inflates the balloon, the patient may experience some form of urine bypass due to the poor seating of the balloon in the bladder.
  • Action
    Bard is providing users with the correct inflation volumes for the affected products. This action has been closed-out on 30/08/2016.

Device

2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distribute...
  • Model / Serial
    2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distributed between June 2013 to June 2015Multiple product and catalogue numbers affectedARTG Number: 158417
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd