Events

Safety Alert for Single Use Home Ventilation Breathing Circuit

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

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
    2017-10-27
  • Event Date Posted
    2017-10-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171027b.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 & paykel healthcare single use home ventilation breathing circuit the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has posted a medical device safety alert concerning single use home ventilation breathing circuit, manufactured by fisher & paykel healthcare. [reference number: rt443; lot numbers: from lot 2100089390 to lot 2100233760] the manufacturer is initiating a voluntary recall of the products due to an increased rate of split tubing cuffs in catheter mounts manufactured on specific dates. a split tubing cuff on the catheter mount may potentially cause a leak, which could lead to patient hypoxaemia if undetected. users are advised to take the following actions: identify any affected products in their inventory by checking the ref and lot number on the packaging. for the affected products, disconnect the catheter mount component, cut this in half and then dispose the entire kit. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-16-to-20-october-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 october 2017.

Device

Single Use Home Ventilation Breathing Circuit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Fisher & Paykel Healthcare Single Use Home Ventilation Breathing Circuit
  • Manufacturer
    Fisher & Paykel Healthcare

Manufacturer

Fisher & Paykel Healthcare