Events

Alerta De Seguridad para Pre-filled Syringes of Saline

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Changzhou Zhiye Medical Devices Institute.

¿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
    2012-07-31
  • Fecha de publicación del evento
    2012-07-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120731.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: changzhou zhiye pre-filled syringes of saline the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a field safety notice concerning a specific lot (lot number: 20100420, expiry date: 20/4/2013) of pre-filled syringes of saline (lmpfss) manufactured by changzhou zhiye medical devices institute, and supplied by l.In.C medical systems in the uk. according to the safety alert, there has been some discoloration in the syringes, which indicates a possible contamination and is potentially dangerous to patients. 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 products, please contact your supplier for necessary actions. posted on 31 july 2012.

Device

Pre-filled Syringes of Saline

Manufacturer

Changzhou Zhiye Medical Devices Institute