Events

Recall of Bard StatLock Catheter Stabilisation Device

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-01605-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01605-1
  • 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 recently become aware that some statlock catheter stabilisation device single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).If the statlock were used beyond its expiration date and became unstable, it may provide sub-optimal securement or stabilisation.
  • Action
    Customers who have purchased the affected stock are being provided with the missing unique product identifiers (product code, lot number, expiration date, etc.). This action has been closed-out on 25/05/2017.

Device

Bard StatLock Catheter Stabilisation Device
  • Model / Serial
    Bard StatLock Catheter Stabilisation Device Product Code: CV0220Lot Number: JUAPF369Expiry Date: 31-Jan-2019ARTG Number: 141586
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd