Events

Alerta De Seguridad para Octopus-3 x Anti-reflux Valves + Clamps

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

¿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
    2011-10-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111010.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
    Mhra field safety notice: octopus-3 x anti-reflux valves + clamps the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that octopus-3 x anti-reflux valves + clamps manufactured by vygon sa may not be able to deliver infusion by gravity. according to the manufacturer, there is a number of products of batch number 080411ae which may incorporate an anti-syphon valve instead of an anti-reflux valve due to a production error. in the event of a device incorporating an anti-syphon valve being used for a gravity infusion, the infusion will not reach the patient. the manufacturer is recalling the product. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please quarantine the remaining stock and contact your supplier for necessary actions.

Device

Octopus-3 x Anti-reflux Valves + Clamps
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Octopus-3 x Anti-reflux Valves + Clamps
  • Manufacturer
    Vygon SA

Manufacturer

Vygon SA