Events

Alerta De Seguridad para Disposable Nitrile and Latex Inspection Gloves without Powder ELA

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por LAG Khai Hoan JSC., Vietnam.

¿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
    3
  • Fecha
    2018-02-23
  • 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 do not bear the ce marking (does not meet the requirements of points 38 and 39 of the regulation); the packaging of the medical device is indicated by an authorized representative of emergo europe bv (the netherlands), and the authorized representative of the manufacturer in the customs documentation is designated by unimedica ltd (bulgaria). a manufacturer who places medical devices on the market in his own name and has no registered office in the european economic area must appoint one authorized representative in the european economic area (not in compliance with the requirements of article 45 of the regulation).
  • Acción
    Do not allow to enter the Lithuanian market

Device

Disposable Nitrile and Latex Inspection Gloves without Powder ELA

Manufacturer

LAG Khai Hoan JSC., Vietnam
  • Representante del fabricante
    UAB Skirgesa
  • Source
    MH