Events

Safety Alert for Stat 2 flow controller

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

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
    2014-10-03
  • Event Date Posted
    2014-10-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141003c.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: conmed stat 2 flow controller the u.S. food and drug administration (fda) posted a medical device safety alert concerning stat 2 flow controller, manufactured by conmed. the affected products may deliver a significantly higher flow rate than was intended. the manufacturer is recalling the conmed stat 2 flow controller for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=69088&w=10012014〈=eng if you are in possession of the product, please contact your supplier for necessary actions. posted on 3 october 2014.

Device

Stat 2 flow controller
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ConMed Stat 2 flow controller
  • Manufacturer
    ConMed

Manufacturer

ConMed