Events

Safety Alert for Octopus-3 x Anti-reflux Valves + Clamps

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

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
    2011-10-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111010.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
    Mhra field safety notice: octopus-3 x anti-reflux valves + clamps the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that octopus-3 x anti-reflux valves + clamps manufactured by vygon sa may not be able to deliver infusion by gravity. according to the manufacturer, there is a number of products of batch number 080411ae which may incorporate an anti-syphon valve instead of an anti-reflux valve due to a production error. in the event of a device incorporating an anti-syphon valve being used for a gravity infusion, the infusion will not reach the patient. the manufacturer is recalling the product. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please quarantine the remaining stock and contact your supplier for necessary actions.

Device

Octopus-3 x Anti-reflux Valves + Clamps
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Octopus-3 x Anti-reflux Valves + Clamps
  • Manufacturer
    Vygon SA

Manufacturer

Vygon SA