Events

Alerta De Seguridad para SLEEVE FOR NON SURGICAL PROCEDURE AMBI TEX STERILE AND NON-STERILE - Reg. 10170480010; GLOVE FOR NON-SURGICAL PROCEDURE AMBI EX - Reg. 10170480011; SLEEVE FOR NON SURGICAL PROCEDURE SANRO AMBI TEX NON-STERILE - Reg. 10170480015. - ALL LOTS

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Fábrica de Artefatos de Látex São Roque S/A.

¿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
    1065
  • Fecha
    2011-07-01
  • 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 DRC 05 of February 15, 2008, surgical gloves and gloves of non-surgical procedures of natural rubber, synthetic rubber or mixture of natural and synthetic rubbers, under sanitary surveillance regime, must meet the conformity certification requirements in the (SBAC).) ### UPDATE - 12/01/2012 - The Certification body communicates that the corrective actions were satisfactory, granting new Authorship for Use of the Conformity Identification Seal. #
  • Causa
    Annual maintenance tests as shown in the mechanical test reports ela / l-207.160 / 3/4/5/6/11 (evidence) and ela / l-208.433 / 1/2/3/4/11 -proof).
  • Acción
    All products relating to these models must be segregated for destruction.

Device

SLEEVE FOR NON SURGICAL PROCEDURE AMBI TEX STERILE AND NON-STERILE - Reg. 10170480010; GLOVE FOR ...

Manufacturer

Fábrica de Artefatos de Látex São Roque S/A
  • Empresa matriz del fabricante (2017)
    Sotex Ltda.
  • Source
    ANVSANVISA