Events

Alerta De Seguridad para Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM Technical Name: Vascular Suture ANVISA Registration Number: 80146501477 Hazard Class: IV Model Affected: Serial Numbers Affected: 5020141; 6041941; 6051141; 6051341

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil LTDA; Abbott Vascular.

¿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
    2170
  • Fecha
    2017-02-07
  • 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
    Abbott Vascular will inform / request customers who received units from those lots: • check the list of affected lots on the customer's chart; • The use of devices of the indicated batches should be discontinued immediately; • Review stock and complete the effectiveness check form; • Return all identified products that have not been used to Abbott Vascular. • Share this information with relevant people in your organization; • This action does not affect patients who have successfully undergone cardiac or endovascular procedures using the StarClose SE Vascular Closure System.
  • Causa
    Abbott vascular has identified that indicated batches of the starclose se product may have difficulty or failure to deploy the starclose se clip.
  • Acción
    Field Action Code February 10, 2017 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will collect.

Device

Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM Technical Name: Vascular Suture ANVISA Registrat...

Manufacturer

Abbott Laboratórios do Brasil LTDA; Abbott Vascular
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA