Events

Alerta De Seguridad para Product: Disposable Needle EMBRAMAC 0.7x30 (22G 1 ¼) -. ANVISA Register 10201230081 -. Lot 200946

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ZHEJIAN OUJIAN MEDICAL APPARATUS CO. LTD.

¿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
  • ID del evento
    1318
  • Fecha
    2013-10-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    COMPANY DETENTING THE REGISTRY IN BRAZIL: Embramac - Brazilian Surgical Material Company Indústria Comércio Importação e Exportação Ltda - CNPJ 51.285.641 / 0001-70-Rua Pedro Ferreira155, Salas 206/215-Itajaí / SC ///// UPDATE - A the company completed the collection action and the units collected were sent for decharacterization, according to ID: RCR / LA / 0647/14.
  • Causa
    Unsatisfactory aspect test - presence of foreign body, according to the reports of analysis nº 591.00 / 2013 and nº 895.00 / 2013, issued by the adolfo lutz institute of the state of são paulo; and the single sample tax review expertise.
  • Acción
    ANVISA determined, as a measure of sanitary interest, the suspension of distribution, commerce and use, throughout the national territory, as well as the collection of stock in the market.

Device

Product: Disposable Needle EMBRAMAC 0.7x30 (22G 1 ¼) -. ANVISA Register 10201230081 -. Lot 200946

Manufacturer

ZHEJIAN OUJIAN MEDICAL APPARATUS CO. LTD
  • Source
    ANVSANVISA