Events

Recall of Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter)

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-00555-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00555-1
  • 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 access systems has received reports involving an incorrect connector colour indicated on the product labelling for specific lots of the replacement connector for groshong nxt picc (for use with groshong nxt, 5 fr. dual-lumen picc). the case label for the specific lot incorrectly identified the connector colour as “white”. the connector is red and is correctly identified by the unit label as “red”.
  • Action
    Bard is advising users to be aware of the issue. The affected product remains safe to use and there is no requirement to return the affected product. This action has been closed-out on 25/01/2017.

Device

Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter)
  • Model / Serial
    Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter) Product Code: 7812500 Lot Number: REVH0705ARTG Number: 136492
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd