Events

Recall of Hickman and Leonard Central Venous Catheter Kits Multiple product codes affected

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-2016-RN-00411-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00411-1
  • 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
    There is an incorrect expiration date on the product labelling for specific lots of hickman and leonard central venous catheter kits. the expiration date for the needle provided in these specific kits was not reflected in the unit or case expiration date label.
  • Action
    Bard is advising users that affected stock can continue to be used in accordance with the corrected expiry dates provided with the recall letter. There is no requirement to return affected product. This action has been closed out on 25/01/2017.

Device

Hickman and Leonard Central Venous Catheter Kits Multiple product codes affected
  • Model / Serial
    Hickman and Leonard Central Venous Catheter Kits Multiple product codes affectedMultiple lot numbers affectedARTG numbers:145468 & 145469
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd