Events

Safety Alert for Blood storage containers I-STEAM

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
    4
  • Date
    2015-04-13
  • 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 packs of i-stem blood storage containers do not contain data on the manufacturer, the manufacturer's authorized representative in the european economic area, the batch / serial number, the expiry date. the individual packs of medical devices are marked with the ce conformity marking, which does not conform to the requirements.
  • Action
    Disallowed to market

Device

Blood storage containers I-STEAM

Manufacturer

MP Manufacturer unknown Sintee: AG Skinlab Trade, Korea
  • Manufacturers representative
    JSC "Estetus klinika"
  • Source
    MH