Events

Alerta De Seguridad para KIMGUARD Container Filters

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Kimberly-Clark 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
    2013-03-18
  • Fecha de publicación del evento
    2013-03-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130318.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: kimberly-clark kimguard container filters medical device manufacturer, kimberly-clark corporation issued a medical device safety alert concerning 9in. x 9in. (23cm x 23cm) square sized kimguard container filters. the affected product code is 68509 and the affected lot numbers are mf1279xxx, mf1287xxx, mf1288xxx. according to the manufacturer, some individual container filter units from the above product lots might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. complaints received so far involved defects that were identified prior to use of possibly affected instruments or supplies on patients. kimberly-clark stressed that standard practice involves inspecting the sterilization container and filter for sterility breaches prior to use. if the defect is not detected upon standard inspection, contamination of surgical instruments and supplies within the container could be resulted. kimberly-clark asia pacific health care confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 march 2013.

Device

KIMGUARD Container Filters
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Kimberly-Clark KIMGUARD Container Filters
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation