Events

Safety Alert for OxyTOTE Valve Integrated Pressure Regulators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Western / Scott Fetzer Co.

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
    2015-02-02
  • Event Date Posted
    2015-02-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150202.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: western / scott fetzer co. oxytote valve integrated pressure regulators health canada posted a medical device safety alert concerning oxytote valve integrated pressure regulators (viprs) [model numbers: mnr-600, mns-603, mtr-500, mtr-700, mts-501, mts-502, mts-503], manufactured by western / scott fetzer co. the manufacturer decided to initiate this recall based on reports of ignition events involving oxytote valve integrated pressure regulators (viprs) and the subsequent investigations into those events. based on the investigations, the manufacturer has become aware of the possibility of ignition and rupture (i.E., explosion) of the compressed gas oxygen cylinder, which can cause serious injury and/or death. for details, please refer to the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2015/43563r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 february 2015.

Device

OxyTOTE Valve Integrated Pressure Regulators

Manufacturer

Western / Scott Fetzer Co