Events

Alerta De Seguridad para hook-up kits containing non-sterile alcohol prep pads

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

¿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
    2011-11-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111123.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: spacelabs healthcare hook-up kits containing non-sterile alcohol prep pads the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on spacelabs healthcare’s hook-up kits containing non-sterile alcohol prep pads. spacelabs healthcare reported that non-sterile alcohol prep pads that contained in some of their hook-up kits, may have the presence of a bacterium, bacillus cereus, which could lead to life-threatening infection. spacelabs healthcare suggests the users to stop using these alcohol prep pads immediately and dispose them according to hospital or clinic protocol. 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 contact your supplier for necessary actions.

Device

hook-up kits containing non-sterile alcohol prep pads
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Spacelabs Healthcare hook-up kits containing non-sterile alcohol prep pads
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare