Events

Alerta De Seguridad para Polymer containers for disinfecting and preparing medical instruments for sterilization: EDPO3-01, EDPO-5-01 and EDPO-10-01

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por JSC Yelatma Instrumental Making Enterprise (Elamed company), Russia.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    2
  • Fecha
    2018-07-04
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Representante del fabricante
    UAB Skirgesa
  • Source
    MH