Alerta De Seguridad para 5/10/12mm Armoured Swing-top

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

¿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
    2017-09-19
  • Fecha de publicación del evento
    2017-09-19
  • 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
    Medical device safety alert: surgical innovations ltd 5/10/12mm armoured swing-top medical device manufacturer, surgical innovations ltd, has issued a medical device safety alert concerning its instrument, 5/10/12mm armoured swing-top [part number: ya512stsa; lot number: 703340]. there is a labelling error on the above-mentioned product. the devices are sterile, however the label states non-sterile. in particular, the label on the device (primary packaging) is labelled incorrectly and states “non-sterile”. the label on the carton (secondary packaging) is correct and states “sterile”. according to the manufacturer, this does not impact the quality of the product, the product is sterile and there is no risk to patient safety. a steri-dot is applied to each primary and secondary packaging to indicate the batch has been sterilised. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 september 2017.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Surgical Innovations Ltd 5/10/12mm Armoured Swing-top
  • Manufacturer

Manufacturer