Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Abbott Vascular Devices Div Abbott Laboratories Inc.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 010 12 13 000
  • Fecha de inicio del evento
    2013-12-02
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4860
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Abbott vascular has initiated a voluntary field action for ht connect peripheral guide wires due to a small number of devices exhibiting partial delamination of the ptfe coating.

Device

HT Connect Peripheral Guide Wires
  • Modelo / Serial
    Part Number : Description 1012587 : 018 HT CONNECT 145 CM 1012588 : 018 HT CONNECT 195 CM 1012589 : 018 HT CONNECT 300 CM 1012590 : 018 HT CONNECT FLEX 145 CM 1012591 : 018 HT CONNECT FLEX 195 CM 1012592 : 018 HT CONNECT FLEX 300 CM 1012593 : 018 HT CONNECT 250T 145 CM 1012594 : 018 HT CONNECT 250T 195 CM 1012595 : 018 HT CONNECT 250T 300 CM
  • Descripción del producto
    Guide wires
  • Manufacturer
    Abbott Vascular Devices Div Abbott Laboratories Inc

Manufacturer

Abbott Vascular Devices Div Abbott Laboratories Inc
  • 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.
  • Representante del fabricante
    Gulf Medical Co., Jeddah, (02) 6512828
  • Source
    SFDA