Events

Safety Alert for Sterile surgical threads with needles

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Not specified.

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
    4
  • Date
    2017-05-17
  • 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
    Examination of the information in the european database of medical devices eudamed has shown that the same purpose medical devices of other manufacturers are certified; the medical devices do not bear the ce marking and the number of the notified body (not in compliance with points 38, 39 and 40 of the regulation); there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (not in compliance with point 14.3.1 of annex 1 to the regulation); there is no indication that the medical device is sterile (does not comply with point 14.3.3 of annex 1 to the regulation); the date (month and year) on which the medical device may be used safely on the label of the medical device (does not comply with point 14.3.5 of annex 1 to the regulation); there is no indication that medical devices are intended for single use (not in compliance with annex 1, paragraph 14.3.6 of the regulation); no special storage conditions for medical devices (not in compliance with annex 1, paragraph 14.3.9 of the regulation); warnings and / or precautionary measures not provided (not in accordance with annex 1, point 14.3.11 of the regulation); all information on the medical device packages is not in the european community language and the information provided is not identifiable (does not comply with article 4 (4) of council directive 93/42 / eec).
  • Action
    Not allowed to enter the Lithuanian market

Device

Sterile surgical threads with needles

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH