Events

Recall of Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC 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-2015-RN-00036-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00036-1
  • 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
    Navilyst medical is recalling picc catheters that contain valve(s) manufactured prior to october 9, 2013. use of these picc catheters may have an increased incidence of hemolyzed blood samples which may require additional peripheral access or replacement of the picc catheter.Valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the picc catheter and they are not subject to this recall action.Types of tests affected include blood chemistries such as electrolytes and blood count measurements such as hemoglobin and hematocrit as they can be altered by hemolysis.To date, no patient injuries have been reported to navilyst medical as a result of this issue.
  • Action
    Customers are asked to inspect and quarantine affected stock for return to Navilyst Medical as per the directions in the Customer Letter. This action has been closed-out on 18/07/2016.

Device

Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/Kits

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia