Alerta De Seguridad para Product name: Catheter Centimetrate Technical name: Catheter ANVISA registration number: 10212990193 Hazard class: IV Target group: NR5.0-35-100-P-10S-PIG-CSG-20

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por COOK INCORPORATED.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    Analyze whether these recalled items are still physically in your inventory, then the items should be immediately segregated; Contact E. Tamussino & Cia Ltda so that we can align the return of these catheters; Circulate the Recall Notice internally for all interested / affected parties; Inform E.Tamussino if any of the devices mentioned in this notice have been distributed to other organizations. Please provide contact details so that E.Tamussino can inform recipients accordingly. If you are a Distributor, please note that you are responsible for notifying your affected customers. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Cook medical is voluntarily recalling specific batches. a degradation of the polymers forming the tip of the catheter has been identified which results in the division or separation of the catheter tip.
  • Acción
    Field Action Code T10071-32, T10071-34, T10071-35, T10071-36, T10071-37, T10071-38, T11747-3, T11747-6, T11747-8 triggered under the responsibility of the company E. TAMUSSINO. Company will make collection for later return to the manufacturer.