Events

Alerta De Seguridad para AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume and AlgiNot Volume FS

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Kerr 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
    2012-06-27
  • Fecha de publicación del evento
    2012-06-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120627b.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: kerr alginot cartridge, alginot cartridge fs, alginot volume and alginot volume fs medical device manufacturer, kerr corporation, has issued a medical device safety alert concerning alginot cartridge, alginot cartridge fs, alginot volume and alginot volume fs. they found that the current instructions for use (ifus) for alginot include product specifications and instructions that are not indicative of the actual performance of the product. the ifus incorrectly state the work time/mouth removal time. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 27 june 2012.

Device

AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume and AlgiNot Volume FS
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Kerr AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume and AlgiNot Volume FS
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation