Events

Safety Alert for Polymer containers for disinfecting and preparing medical instruments for sterilization: EDPO3-01, EDPO-5-01 and EDPO-10-01

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by JSC Yelatma Instrumental Making Enterprise (Elamed company), Russia.

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
    2
  • Date
    2018-07-04
  • 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
    Container disinfection does not include the name and address of the manufacturer, the name and address of the manufacturer's authorized representative in the european economic area, the details of the authorized representative in neither the instructions for use nor the transport packaging - do not meet the requirements of annex 1, paragraph 14.3.1 of the regulation; batch / serial number not specified for container disinfection - not in accordance with annex 1, paragraph 14.3.4 of the regulation; manufacturer's instructions for use in the container for disinfection in english are indicated by the ce conformity marking, followed by the number of the notified body 0044. the container for disinfection is classified as class i medical devices and is not sterile and has no measuring function. in accordance with the requirements of the regulation, such medical devices shall only be labeled with the ce conformity marking without the number of the notified body. considering this, the instructions for use of container disinfection are marked in violation of the requirements of article 40 of the regulation.
  • Action
    Do not allow to enter the Lithuanian market

Device

Polymer containers for disinfecting and preparing medical instruments for sterilization: EDPO3-01...

Manufacturer

JSC Yelatma Instrumental Making Enterprise (Elamed company), Russia
  • Manufacturers representative
    UAB Skirgesa
  • Source
    MH