Events

Safety Alert for Guardian II and Guardian II NC Hemostasis Valves

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

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
    2013-03-04
  • Event Date Posted
    2013-03-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130304.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: vascular solutions guardian ii and guardian ii nc hemostasis valves medical device manufacturer, vascular solutions inc., has issued a medical device safety alert concerning guardian ii and guardian ii nc hemostasis valves. the affected model numbers are fh101, fh101-t, fh101-25, fh101-50, fh102, fh102-t, fh102-25 and fh102-502. there is a low risk that air may be introduced into certain lots of the device, which may lead to an air embolism. due to the potential harm, the manufacturer is recalling the affected products. the root cause of the problem is related to a slight reduction in the outside diameter (still within validated tolerances) of the wiper seal of the device. the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 march 2013.

Device

Guardian II and Guardian II NC Hemostasis Valves

Manufacturer

Vascular Solutions Inc.