Alerta De Seguridad para CATHETER FOR ANGIOGRAPHY CORDIS *, registration no. 10132590545, manufactured between July 2005 and February 2006.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Cordis Corporation;Cordis Europa N. V..

¿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
    840
  • Fecha
    2006-09-27
  • 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
    Cordis Corporation has found that a small number of these catheters manufactured between July 2005 and February 2006 may have potential separation between the tip and the body. The reported incident rate was less than 0.002%. The Technovigilance Unit is monitoring the company's actions. *************************************** ********** Update 10/10/2006 ******************************** Second to Source, customer complaints regarding the product affected by the recall have not been recorded to date, and all affected customers have already been contacted. The products have already been collected and are in the warehouse of the Johnson & Johnson Logistics Operator at a quarantine site awaiting the start of the destruction process.
  • Causa
    Possibility of separation between the tip and the body of the cater during the surgical procedure.
  • Acción
    Johnson & Johnson Professional Products has already forwarded the recall communication to all tracked customers and has already initiated the recall process.

Manufacturer