Events

Recall of SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration Set

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-2013-RN-01289-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01289-1
  • 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
    Following reports of leaking from the in-line safsite injection site, initial investigations have identified that on disconnection of a luer connector used to access the injection site, a resealing issue may occur intermittently. this may result in fluid leaking from the valve.
  • Action
    As an interim corrective action, B.Braun is recommending that end users fit a stand-alone Safsite valve to the in-line injection site. The valve can be used for injection or infusion and does not need to be removed. Further notifications will be undertaken if any additional actions are required based on B. Braun's investigations.

Device

SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration Set
  • Model / Serial
    SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration SetArticle code: 4050193Batch number: 3H24278T34ARTG Number: 137615HEIDELBERG EXTENSION TUBINGArticle code: 4052197 Batch number: 3H21278A23ARTG Number:139265
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd