Events

Safety Alert for Hudson RCI Pediatric Anaesthesia Breathing Circuits

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
    2014-10-08
  • Event Date Posted
    2014-10-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141008.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 pediatric anaesthesia breathing circuits the united states food and drug administration (fda) issued a medical device safety alert concerning hudson rci pediatric anaesthesia breathing circuits, manufactured by teleflex medical. the affected products were manufactured from march 2013 to july 2014 and distributed from june 2013 to may 2014. according to the fda, the ends of the devices may crack or break before or during use. this could cause serious health risks, including delayed patient treatment and breathing difficulties if not replaced immediately. use of this device may also cause death. on september 8, 2014, the manufacturer sent customers an urgent medical device recall letter explaining the device problem and actions to be taken. the manufacturer recommends the following actions:- stop using the devices. remove the devices from inventory and stop distribution. for details, please refer to the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm417868.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm417731.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 october 2014.

Device

Hudson RCI Pediatric Anaesthesia Breathing Circuits
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Medical Device Safety Alert: Teleflex Medical Hudson RCI Pediatric Anaesthesia Breathing Circuits
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical