Events

Alerta De Seguridad para Extrude Wash

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
    2012-06-08
  • Fecha de publicación del evento
    2012-06-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120608a.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 extrude wash medical device manufacturer, kerr corporation, has issued a customer notification on extrude wash, part no. 28418 - 2 pack, 28419 - 32 pack and 29036 - value pack (all production lots within shelf life). kerr corporation found that the current direction for use for extrude wash lists a working time that is not indicative of the actual performance of the product. there is no safety or efficacy concerns associated with extrude wash as the product will set. according to the manufacturer, the affected products have been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 8 june 2012.

Device

Extrude Wash
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Kerr Extrude Wash
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation