Events

Safety Alert for Protect-A-Line IV extension set

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

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
    2013-08-20
  • Event Date Posted
    2013-08-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130820a.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: vygon protect-a-line iv extension set the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning protect-a-line iv extension set (supplied with vented caps) manufactured by vygon. the affected product code is 0832.04 and all batch numbers ending in the letters ba are affected. according to the mhra, there is a risk of air embolus because the affected devices have been supplied with vented caps on the female port (y-site) instead of non-vented caps. identify affected devices. prior to use, remove vented caps from the female port (y-site) of affected devices and replace them with non-vented caps (or a needle free connector) if this port is to remain unused when the set is connected to a patient. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con306143 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2013.

Device

Protect-A-Line IV extension set
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Vygon Protect-A-Line IV extension set
  • Manufacturer
    Vygon

Manufacturer

Vygon