Events

Recall of Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok

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-01095-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01095-1
  • 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
    Bard has identified that some devices from a specific lot of product have a potential breach of the sterile barrier packaging. this defect may put patients at an increased risk of an ascending urinary tract infection. symptoms of an infection could include fever, pain and burning sensation upon voiding.
  • Action
    Bard is requesting users inspect their stocks and to quarantine affected units prior to return as per the instructions in the customer letter. If customers have used any affected product, monitor the relevant patients for symptoms and signs of localised and/or systemic infection. This action has been closed-out on 22/08/2016.

Device

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok
  • Model / Serial
    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok Catalogue Number: 154006Lot Number: NGYJ0603ARTG Number: 195134
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd