Events

Alerta De Seguridad para ViaSpan

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

¿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
    2012-03-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120329.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
    Field safety notice: bristol-myers squibb viaspan it comes to our attention that that there is a potential of product contamination for viaspan supplied by bristol-myers squibb pharmaceuticals ltd (bms). viaspan is a solution for the preservation of kidney, liver and pancreas. the product is manufactured by fresenius kabi in austria, and is supplied to a number of countries around the world. bacillus cereus has been cultured from the fresenius production line but not from the product itself. as a precautionary measure, bms has decided to put on hold, pending the completion of the investigation, all the lots manufactured since july 2011. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

ViaSpan
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bristol-Myers Squibb ViaSpan
  • Manufacturer
    Fresenius Kabi in Austria

Manufacturer

Fresenius Kabi in Austria