Events

Recall of Vaxcel and Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC Triple Lumen with Endexo and PASV Valve Technology/Kits

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-00383-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00383-1
  • 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
    The manufacturer, navilyst medical is recalling picc catheters that contain valve(s) manufactured prior to 15 july 2014. valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of haemolysis during blood sampling through the picc catheter. use of the picc catheters that are subject to this recall may have an increased incidence of haemolysed blood samples which may require additional peripheral access or replacement of the picc catheter. to date, no patient injuries have been reported to navilyst medical as a result of this issue.
  • Action
    Emergo is advising users to inspect stock and return any unused affected product to the distributor. This action has been closed-out on 30/01/2017.

Device

Vaxcel and Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC Triple Lumen with Endexo and P...
  • Model / Serial
    Vaxcel and Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC Triple Lumen with Endexo and PASV Valve Technology/KitsMultiple models affectedMultiple lot numbers affectedARTG Numbers: 178780, 203831
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia