Events

Alerta De Seguridad para GLOVE FOR NON-SURGICAL PROCEDURE WITHOUT POWDER LAGROTTA AZZURRA - Registered in Anvisa under the number 80044540021 - All batches.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Descartáveis Non Woven Importação e Exportação Ltda.

¿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
    1094
  • Fecha
    2011-09-29
  • 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
    According to RDC 05, of February 15, 2008, the certification of gloves is a prerequisite for its commercialization. INMETRO, through its Ordinance 233/2008, establishes the directives for such certification. #### UPDATE - 08/20/2012 - The Certifying Body - Institute for Certification for Excellence in Compliance - ICEPEX, communicates through the dossier (NP / ICEPEX-I 12246/2011 and NP / ICEPEX-I 12704 / 2011-1), which may be marketed. ###
  • Causa
    Periodic certification maintenance tests were not performed.
  • Acción
    All the products mentioned herein must be identified and segregated by professionals and services and maintained contact with the registry holder for collection and subsequent destruction.

Device

GLOVE FOR NON-SURGICAL PROCEDURE WITHOUT POWDER LAGROTTA AZZURRA - Registered in Anvisa under the...

Manufacturer

Descartáveis Non Woven Importação e Exportação Ltda
  • Source
    ANVSANVISA