Events

Alerta De Seguridad para Guardian II Hemostasis Valve

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

¿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
    2016-03-30
  • Fecha de publicación del evento
    2016-03-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160330b.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 hemostasis valve the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning guardian ii hemostasis valve manufactured by vascular solutions. the affected model numbers are fh101, fh101-t, fh101-25 and fh101-50. the affected lot numbers are 41817, 42029, 42068, 42409, 42410, 42687, 42688, 42689, 42691, 42692, 42693, 42699, 42700, 42701, 42986, 42987, 42988, 42989, 43186, 43187, 43188 and 43408. investigation of a recent complaint has made the manufacturer aware of a potential problem with the click version of the guardian ii hemostasis valve. the low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism. according to the manufacturer, no air ingress or patient harm has been reported. the manufacturer advises affected users to identify and remove all affected devices. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-21-march-to-25-march-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 march 2016.

Device

Guardian II Hemostasis Valve

Manufacturer

Vascular Solutions