Alerta De Seguridad para Fire Star™ Rx PTCA Dilatation Catheter

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

¿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
    2012-06-12
  • Fecha de publicación del evento
    2012-06-12
  • 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: cordis fire star™ rx ptca dilatation catheter medical device manufacturer, cordis corporation, has issued a field safety notice concerning cordis fire star™ rx ptca dilatation catheter. the manufacturer is recalling lot 15437344 of cordis fire star™ rx ptca dilatation catheter (catalog number 8012020d) because it has identified that products of the affected lot has a potential to exhibit “slow deflation” or “no deflation”. according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted 12 jun 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cordis Fire Star™ Rx PTCA Dilatation Catheter
  • Manufacturer

Manufacturer