Events

Alerta De Seguridad para S.M.A.R.T. ® CONTROL® Nitinol Stent System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Cordis.

¿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
  • Fecha
    2012-02-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120202c.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: cordis s.M.A.R.T. ® control® nitinol stent system medical device manufacturer, cordis, a johnson & johnson company, has issued a field safety notice on cordis s.M.A.R.T. ® control® nitinol stent system product. cordis has identified a potential sterility breach in the pouches of all unexpired lots (lot number 15525516 and below) of cordis s.M.A.R.T. ® control® nitinol stent system product with the 65 catalog numbers. cordis revealed that the potential defect was detected during in-house testing on non-production product as part of a development project. further investigation determined that conditions leading to a potential pathway through the seal exist in a small percentage of distributed products. since the compromised seal is not readily apparent to the unaided eye and using of a non-sterile device may expose the patient to increased risk of infection, cordis has decided to recall the product. according to the local supplier, the affected product has been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

S.M.A.R.T. ® CONTROL® Nitinol Stent System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System
  • Manufacturer
    Cordis

Manufacturer

Cordis