Events

Safety Alert for Ultra PC% Cabinet Mount Flowmeters

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Accutron Inc.

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
    2012-10-08
  • Event Date Posted
    2012-10-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121008.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: accutron ultra pc% cabinet mount flowmeters the united states food and drug administration (fda) has posted a firm press release concerning ultra pc% cabinet mount flowmeters, manufactured by accutron inc. accutron, inc., issued a nationwide recall of two hundred and six (206) ultra pc% cabinet mount flowmeters. some of the flowmeters have been found to release nitrous oxide gas when the oxygen is turned off. a flowmeter releasing nitrous oxide gas without oxygen could potentially lead to serious injuries like brain damage in patients. only two complaints have been received regarding the above described flowmeter defect. no injuries have been reported to date. the recall includes the following product model numbers: 27025 flowmeter, cm assy 36600-ns ultra pc% cabinet mount package g, no shut offs: 36800-ns ultra pc% cabinet mount package h, no shut offs 36600 ultra pc% cabinet mount package g 36700 cm flowmeter package h 5000 newport flowmeter system 36800 ultra pc% cabinet mount package h 31970 flowmeter cm consumers who have these flowmeters which are being recalled should stop using and return these flowmeters to accutron for free replacement. for details, please refer to the following fda website: http://www.Fda.Gov/safety/recalls/ucm322799.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 8 october 2012.

Device

Ultra PC% Cabinet Mount Flowmeters
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Medical Device Safety Alert: Accutron Ultra PC% Cabinet Mount Flowmeters
  • Manufacturer
    Accutron Inc

Manufacturer

Accutron Inc