Events

Safety Alert for Reusable Breathing Circuit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Fisher and Paykel Healthcare Ltd.

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
    2013-01-08
  • Event Date Posted
    2013-01-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130108.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: fisher and paykel reusable breathing circuit the united states food and drug administration has issued a medical device safety alert concerning reusable breathing circuit [model no.: 900mr068 & lot no.: 110810 & 111020], manufactured by fisher and paykel healthcare ltd. according to the manufacturer, the tubes used in the reusable breathing circuit have pinholes. if these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. usage of the defective device may result in patient death. customers were instructed to examine their inventory and destroy and discard any affected circuits in possession. replacement circuits will be provided to customers. according to the local supplier, the affected products were not distributed in hong kong. for further details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm334446.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm334297.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 january 2013.

Device

Reusable Breathing Circuit

Manufacturer

Fisher and Paykel Healthcare Ltd