Events

Alerta De Seguridad para Adhesive dressings - patches

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por RFX + CARE MANUFACTURING CO., LTD, CHINA.

¿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
    2017-03-21
  • 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
    Medical devices not bearing the ce conformity marking (not in accordance with point 38 of the regulation), no data on the manufacturer and his authorized representative in the european economic area (not in accordance with annex 1, point 14.3.1 of the regulation) not specified in batch / serial number (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); date (year and month) up to which the medical device may be used safely (does not meet the requirement of annex 1, paragraph 14.3.5 of the regulation); that the medical device is intended for single use (does not meet the requirement of annex 1, paragraph 14.3.6 of the regulation).
  • Acción
    Do not allow to enter the Lithuanian market

Device

Adhesive dressings - patches

Manufacturer

RFX + CARE MANUFACTURING CO., LTD, CHINA