Alerta De Seguridad para Cotton Gauze Tissue BP 45x90cm

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Robinson 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
    2011-08-31
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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
    Field safety notice: robinson healthcare cotton gauze tissue bp 45x90cm robinson healthcare has issued a field safety notice to the customers of cotton gauze tissue bp 45x90cm (part code: 7576, lot: 22/06/2011). robinson healthcare has received a report that the product with manufacturing lot 22/06/2011 has not been processed correctly, as indicated by the sterilization indicator. therefore the product cannot be identified as being sterile and must be considered as un-sterile product. robinson healthcare suggests that users should quarantine the manufacturing lot and return the affected product to robinson healthcare for further investigation. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [31 Aug 2011] Robinson Healthcare Cotton Gauze Tissue BP 45x90cm
  • Manufacturer

Manufacturer