Safety Alert for Compressor Nebulizer CompMist

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by MP Manufacturer Unknown Sender: Fure Industry Co., Ltd., China.

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
  • Event Number
    18
  • Date
    2015-08-07
  • Event Country
  • Event Source
    MH
  • Event Source URL
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Extra notes in the data
  • Reason
    Neither the outer packaging of the medical device nor the instructions for use of the medical device bear the ce marking and the number of the notified body. the label of the medical device bears the ce marking of conformity, but there is no notified body number.
  • Action
    Disallowed to market

Manufacturer

  • Manufacturers representative
    UAB Natura Familia
  • Source
    MH