Events

Safety Alert for Xcela Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) Valve Technology / Kits and BioFlo PICC with Endexo and PASV Valve Technology / Kits

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Navilyst Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-01-07
  • Event Date Posted
    2015-01-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150107.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: navilyst medical xcela peripherally inserted central catheter (picc) with pressure-activated safety valve (pasv) valve technology / kits and bioflo picc with endexo and pasv valve technology / kits medical device manufacturer, navilyst medical, inc., has issued a medical device recall concerning xcela peripherally inserted central catheter (picc) with pressure-activated safety valve (pasv) valve technology / kits and bioflo picc with endexo and pasv valve technology / kits. the manufacture is recalling picc that contain valve(s) manufactured prior to 9 october 2013. valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of haemolysis during blood sampling through the picc. according to the manufacturer, use of the affected products may have an increased incidence of haemolyzed blood samples which may require additional peripheral access or replacement of the picc. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 january 2015.

Device

Xcela Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) V...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Navilyst Medical Xcela Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) Valve Technology / Kits and BioFlo PICC with Endexo and PASV Valve Technology / Kits
  • Manufacturer
    Navilyst Medical

Manufacturer

Navilyst Medical