Events

Alerta De Seguridad para ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile

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

¿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
    2012-07-10
  • Fecha de publicación del evento
    2012-07-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120710a.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 ultra fabric reinforced surgical gown x-large, sterile medical device manufacturer, kimberly-clark issued a medical device safety alert concerning ultra fabric reinforced surgical gown x-large, sterile. kimberly-clark has determined that the package seam of the above mentioned products may not remain properly sealed to ensure that the contents of the package are sterile. therefore, the affected products might not be sterile as labeled. kimberly-clark further explained that the package includes a caution statement indicating ‘contents sterile. unless this package is opened or damaged.’ the direct risk associated with this potential failure mode is that use of an affected non-sterile gown in surgery could lead to contamination of the surgical field. however, as the user inspects each package prior to use, the likelihood for use of a non-sterile gown in surgery is considered to be remote. according to kimberly-clark, the affected lots have been distributed in hong kong. kimberly-clark advised the affected users to stop using the impacted product lots. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 july 2012.

Device

ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile
  • Manufacturer
    Kimberly-Clark

Manufacturer

Kimberly-Clark