Events

Safety Alert for Hudson RCI One-Way Valve with Capped Monitoring Port

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Teleflex 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
    2018-04-13
  • Event Date Posted
    2018-04-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180413a.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: teleflex medical hudson rci one-way valve with capped monitoring port therapeutic goods administration (tga), australia, has issued a medical device safety alert concerning hudson rci one-way valve with capped monitoring port [product code number: 1644; lot number: 74k1502092 and 74k1601936], manufactured by teleflex medical. it has been identified by the manufacturer that one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. to date, there have been no injuries reported as a result of this issue. according to the manufacturer, disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death. the users are advised to immediately discontinue use and quarantine any products of the affected lot numbers. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00307-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 april 2018.

Device

Hudson RCI One-Way Valve with Capped Monitoring Port
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Teleflex Medical Hudson RCI One-Way Valve with Capped Monitoring Port
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical