Events

Safety Alert for Sterile Extension Lines 932801, 302223

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Shenzhen X-Way Medical Technology, 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
    6
  • Date
    2016-05-02
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • 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
    The individual packaging of the mp does not bear the ce conformity marking and the notified body no. (does not meet the requirements of mn 4: 2009 38, 39, 40). the manufacturer's address and the manufacturer's authorized representative in the european economic area (hereinafter referred to as the 'authorized representative' in the eea) are not specified anywhere (not in compliance with mn 4: 2009, annex 1, paragraph 14.3.1).
  • Action
    Disallowed to market

Device

Sterile Extension Lines 932801, 302223

Manufacturer

Shenzhen X-Way Medical Technology, China
  • Manufacturers representative
    UAB Kodeta
  • Source
    MH