Events

Safety Alert for Tri-Flo Subglottic Suction System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Vyaire 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
    2018-08-29
  • Event Date Posted
    2018-08-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180829a.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: vyaire medical tri-flo subglottic suction system the united states food and drug administration (fda) has issued a medical device safety alert concerning tri-flo subglottic suction system [part number: cm28010; lot/serial numbers: 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, 0004008255, 0004008256], manufactured by vyaire medical. the manufacturer has discovered potential patient safety risk associated with the use of tri-flow subglottic suction system. the distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body. for details, please refer to the following fda website: https://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm?event=80508 if you are in possession of the products, please contact your supplier for necessary actions. posted on 29 august 2018.

Device

Tri-Flo Subglottic Suction System

Manufacturer

Vyaire Medical