Events

Alerta De Seguridad para KFlow Epic Catheter Range

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

¿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
    2014-10-24
  • Fecha de publicación del evento
    2014-10-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141024.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: kimal kflow epic catheter range medical device manufacturer, kimal, has issued a field safety notice concerning its kflow epic catheter range. the affected product codes (lot numbers) are kfe-hdl-1219-k (0013009), kfe-hdl-1435-pck (0013010), kfe-rsdl-1419-k (0013009), kfe-rsdl-1423-k (0013009), kfe-rsdl-1427-k (0013009), and kfe-rhdl-1423.K (0013009). the above kflow epic products may have a discrepancy with the seal of the breather bags. there may be some cases where the breather bag has failed to seal, meaning the product is no longer sterile. the manufacturer asks users to inspect stock of the above mentioned products and lot numbers. should they identify that the breather bag is not sealed, users should discontinue use, isolate, label and quarantine any stock to prevent continued use. product replacement can be arranged. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 october 2014.

Device

KFlow Epic Catheter Range
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Kimal KFlow Epic Catheter Range
  • Manufacturer
    Kimal

Manufacturer

Kimal