Events

Alerta De Seguridad para DISTRIBUTOR TAP GABMED - 3 taps - 500 PSI-ON - Model HD-04030 - registration 10216830034 - Affected batches 10K07; 10K19; 11A27; 11B03; 11B04; 11C09.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Gabmed Produtos Específicos 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
    1144
  • Fecha
    2012-06-25
  • 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
    The company states that in 2010 its supplier changed the formulation of lubricating oil without informing them. Such changes can cause multiple cracks after 6-12 months, some manifolds have performed well so far. This problem only happened in the manifold manufactured in 2010, since the beginning of 2011 has been changed to another type of lubricating oil. Anvisa is following this action.
  • Causa
    Product has small cracks in its extension.
  • Acción
    To users, immediately stop the use of the affected product, check the batches of the affected product in its stock and segregate, contact the manufacturer to arrange the collection.

Device

DISTRIBUTOR TAP GABMED - 3 taps - 500 PSI-ON - Model HD-04030 - registration 10216830034 - Affect...

Manufacturer

Gabmed Produtos Específicos Ltda.