Events

Retiro De Equipo O Alerta De Seguridad para HT Connect Peripheral Guidewire

Según Central Drugs Standard Control Organization, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en India que fue producido por 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
    Recall / Safety Alert
  • ID del evento
    31-1284-MD/2013-DC
  • Fecha
    2013-12-10
  • País del evento
    India
  • Fuente del evento
    CDSCO
  • URL de la fuente del evento
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notas / Alertas
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • Notas adicionales en la data
  • Causa
    Voluntary field action for ht connect peripheral guidewires due to a small number of devices exhibiting partial delamination of the ptfe coating.
  • Acción
    Abbott Vascular has ceased distribution of the product while evaluating appropriate corrective and preventive actions.

Device

HT Connect Peripheral Guidewire
  • Modelo / Serial
    1012587, 1012588, 1012589, 1012590, 1012591, 1012592, 1012593, 1012594, 1012595
  • Manufacturer
    Abbott Vascular

Manufacturer

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
    CDSCO