Events

Alerta De Seguridad para STERRAD® CYCLESURE® 24 Biological Indicators

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
    2012-05-08
  • Fecha de publicación del evento
    2012-05-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120508.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: advanced sterilization products sterrad® cyclesure® 24 biological indicators medical device manufacturer, advanced sterilization products (asp), has issued a field safety notice concerning sterrad® cyclesure® 24 biological indicators. asp recently determined that certain lots of raw materials, that were rejected during incoming inspection acceptance tests, were used for the manufacture of a specific lot range of sterrad® cyclesure® 24 biological indicators product. the affected lot numbers are 214117, 216117, 217117, 227118 and 228117. according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong and product recall was ongoing. if you are in possession of the products, please contact your supplier for necessary actions. posted 08 may 2012.

Device

STERRAD® CYCLESURE® 24 Biological Indicators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD® CYCLESURE® 24 Biological Indicators
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products