Safety Alert for Disposable sterile needles

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by MP Manufacturer unknown Sintee: AG Skinlab Trade, 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
    2015-04-13
  • 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
    The sterile disposable needle packs do not contain the manufacturer's address. no individual manufacturer information is available on individual sterile disposable packs. neither sterile disposable needle packs nor individual sterile needle packs contain data on the manufacturer's authorized representative in the european economic area. both packs of sterile disposable needles and individual sterile disposable needles contain information in a language other than the european community. cannot be identified on the labels.
  • Action
    Disallowed to market

Manufacturer

  • Manufacturers representative
    JSC "Estetus klinika"
  • Source
    MH