Events

Recall of Lifemed Urinary Drainage Bag with Pump

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-2014-RN-01058-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01058-1
  • 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 australia has received nine (9) reports of the bard australia lifemed urinary drainage bag being incorrectly assembled with the bulb located in the wrong position. incorrect positioning of the bulb in relation to the inlet tube makes it more difficult to use to the product for its intended purpose. no reports of injuries or harm to the patient or user have been reported.
  • Action
    Customers are advised to check all inventory locations within their institution for the affected stock and segregate these items from their inventory for returning to Bard Australia. This action has been closed-out on 01/03/2016.

Device

Lifemed Urinary Drainage Bag with Pump
  • Model / Serial
    Lifemed Urinary Drainage Bag with PumpProduct Code: L153514Lot Number: NGXL1240ARTG Number: 163481
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd