Events

Recall of RX 160 WRIGHT NEBULIZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROXON MEDI TECH LTE..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51818
  • Event Risk Class
    III
  • Event Initiated Date
    2015-11-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The wright rxi6o nebulizer is classified as class ii medical device in canada and does not hold a medical device licence. therefore the sale of the device in canada is in violation of section 26 of the medical devices regulations.

Device

RX 160 WRIGHT NEBULIZER
  • Model / Serial
    Model Catalog: RX160 (Lot serial: All lots)
  • Product Description
    RX 160 WRIGHT NEBULIZER
  • Manufacturer
    ROXON MEDI TECH LTE.

Manufacturer

ROXON MEDI TECH LTE.