Events

Alerta De Seguridad para INTRA VIA Container with PVC Ports

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Baxter 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
    2014-11-17
  • Fecha de publicación del evento
    2014-11-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141117.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: baxter healthcare intra via container with pvc ports the u.S. food and drug administration (fda) posted a medical device safety alert concerning intra via container with pvc ports, manufactured by baxter healthcare. according to the alert, particulate matter was found inside the fluid path of the affected products, including: empty intra via container with pvc ports (sterile, nonpyrogenic fluid path), 500 ml (product code: 2b8013; lot numbers: ur13d15112) empty intra via container with pvc ports, sterile fluid path, 150 ml (product code: 2b8011; lot numbers: ur13d15112) for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=69181&w=11122014〈=eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 17 november 2014.

Device

INTRA VIA Container with PVC Ports

Manufacturer

Baxter Healthcare