Events

Recall of Cavafix (used for the catheterisation of vena cava)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun 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-00419-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00419-1
  • 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
    In the course of internal quality checks the manufacturer discovered that aging of these products can result in deposits of particles on the surface of the catheters. to date, no harm or any other adverse patient outcome which could be associated to the above described observation has been reported to b. braun melsungen ag.
  • Action
    B.Braun is requesting their customers to inspect their stock and quarantine any units from the affected batches. All affected stock will be recovered by B.Braun and a credit note issued. This action has been closed-out on 29/01/2016.

Device

Cavafix (used for the catheterisation of vena cava)
  • Model / Serial
    Cavafix (used for the catheterisation of vena cava)Article Code: 4152557, 4173350, 4173759 All batchesARTG Number: 142123
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd