Events

Alerta De Seguridad para Guardian II and Guardian II NC Hemostasis Valves

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

¿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
    2013-03-04
  • Fecha de publicación del evento
    2013-03-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130304.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: vascular solutions guardian ii and guardian ii nc hemostasis valves medical device manufacturer, vascular solutions inc., has issued a medical device safety alert concerning guardian ii and guardian ii nc hemostasis valves. the affected model numbers are fh101, fh101-t, fh101-25, fh101-50, fh102, fh102-t, fh102-25 and fh102-502. there is a low risk that air may be introduced into certain lots of the device, which may lead to an air embolism. due to the potential harm, the manufacturer is recalling the affected products. the root cause of the problem is related to a slight reduction in the outside diameter (still within validated tolerances) of the wiper seal of the device. the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 march 2013.

Device

Guardian II and Guardian II NC Hemostasis Valves

Manufacturer

Vascular Solutions Inc.