Events

Alerta De Seguridad para CHG Cloth Product

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

¿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
    2016-08-26
  • Fecha de publicación del evento
    2016-08-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_201608026a.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: sage chg cloth product medical device manufacturer, sage, has issued a medical device safety alert concerning its chg cloth product [product code: (1) 9601-x and (2) 9602-x; lot numbers: (1) 48339, 49019, 45445; (2) 46269, 46854, 47582, 48999, 49716, 50703, 51611, 52800 and 53093]. the product recall is being initiated due to potential product contamination with burkholderia cepacia. topical administration of a product with presence of microbial contamination may cause serious infections in immuno-compromised persons and in hospitalised patients, as well as certain other patient groups. 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 26 august 2016.

Device

CHG Cloth Product
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Sage CHG Cloth Product
  • Manufacturer
    Sage

Manufacturer

Sage
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH