Events

Alerta De Seguridad para ExoSeal Vascular Closure Device

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

¿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
    2012-11-01
  • Fecha de publicación del evento
    2012-11-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121101.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
    Medical device safety alert: cordis exoseal vascular closure device medical device manufacturer, cordis corporation (a johnson & johnson company), has issued a field safety notice concerning exoseal vascular closure device. the affected catalogue numbers were ex500ce, ex600ce and ex700ce and affected lot numbers ranged from 15466779 to 15682751. expiration dates of the affected products range from july 2013 through july 2014. cordis recently identified that the affected lots of cordis exoseal vascular closure device were sterilized using a process that did not achieve the sterility assurance level that is required by the standards for this class of product. the discrepancy was detected as part of routine quality control testing. according to manufacturer, no complaints have been reported to date that are related to this issue, and there is no significant increased risk of infection to the patient from exposure to the affected products. therefore, there is no concern for patients who have already been treated with the device and no additional patient follow-up is required. according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

ExoSeal Vascular Closure Device
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cordis ExoSeal Vascular Closure Device
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation