Alerta De Seguridad para CIDEX Activated Glutaraldehyde Solution

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

¿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
    2015-08-04
  • Fecha de publicación del evento
    2015-08-04
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: advanced sterilization products cidex activated glutaraldehyde solution medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its cidex activated glutaraldehyde solution. the manufacturer recently determined, as part of its routine quality program, that it may lack the adequate data to support the entire 24-month shelf life of cidex activated glutaraldehyde solution. the manufacturer determined that data for cidex activated glutaraldehyde solution supports a 12-month shelf life. the cidex activated glutaraldehyde solution is currently labeled for a 24-month shelf life. while the product has a maximum 14-day reuse life, data shows that the ph level of the cidex activated glutaraldehyde solution may be below specification for up to 2 hours after activation. use of cidex activated glutaraldehyde solution after 12 months may result in inadequate medical device reprocessing (disinfection/sterilization) or re-contamination if it is used for reprocessing within the first 2 hours of activation. the manufacturer advises users to check the expiration date on all bottles of cidex activated glutaraldehyde solution currently in inventory. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 august 2015.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Advanced Sterilization Products CIDEX Activated Glutaraldehyde Solution
  • Manufacturer

Manufacturer