Events

Safety Alert for Sterile thread with needles

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Allure Korea Co., Ltd., Korea.

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
    3
  • Date
    2017-03-21
  • 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
    There is no data available from the manufacturer's authorized representative in the european economic area (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); batch / serial number not specified (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); after checking the information in the european database of medical devices eudamed, it has been found that the medical devices contained in this consignment are not registered, nor has eudamed found data on the korean manufacturer allure korea co., ltd., korea, and its authorized representative in the european community (does not meet the requirement of paragraph 45 of the regulation) ).
  • Action
    Do not allow to enter the Lithuanian market

Device

Sterile thread with needles

Manufacturer

Allure Korea Co., Ltd., Korea
  • Manufacturers representative
    JSC „Beauty House Aurum“
  • Source
    MH