Events

Alerta De Seguridad para Forceps for biopsy

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Alton (Shanghai) Medical Instruments 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
    1
  • Fecha
    2017-03-07
  • 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
    The label of the medical device does not contain information on the manufacturer's authorized representative in the european economic area (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); after checking the information in the european database of medical devices eudamed, the medical devices contained in this consignment were found not to be registered. eudamed has not found any chinese manufacturer alton (shanghai) medical instruments co., ltd., china, and its authorized representative in the european community (does not meet the requirements of paragraph 45 of the regulation); the label indicates that the medical device is non-sterile and reusable, but the method of sterilization is not specified (does not meet the requirements of annex 1, paragraph 14.3.13 of the regulation). the instructions for use are not included, no label or symbol on the label, instructions for use attached.
  • Acción
    Not allowed to enter the Lithuanian market

Device

Forceps for biopsy

Manufacturer

Alton (Shanghai) Medical Instruments Co., Ltd., China
  • Representante del fabricante
    UAB Medex Baltic
  • Source
    MH