Alerta De Seguridad para GLOVE FOR EXAMINATION AND PROCEDURES DESCARPAK SIZE PP - Registration 10330660014 - 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 Descarpack Descartáveis do Brasil 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
    1066
  • Fecha
    2011-07-06
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 of the Brazilian Conformity Assessment System (SBAC). ### UPDATE - Back to 06/12/2011 - The Certification Body - IFBQ announces the withdrawal of the suspension of the Authorization for Use of the Conformity Identification Seal, through the dossier 776231 / 11-3, considering that the measures adopted by the company were satisfactory for the correction of the problems that led to the cancellation, being the product released for import, commercialization and use.
  • Causa
    Failure to perform annual maintenance tests, as demonstrated by the mechanical test reports ela / l-207.917 / 11 (test) and ela / l-209.412 / 11 (counter-test).
  • Acción
    All products relating to this model must be segregated for destruction.

Manufacturer