Events

Alerta De Seguridad para Portex Low Dead Space Connector with Sideport

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

¿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
    2014-06-13
  • Fecha de publicación del evento
    2014-06-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140613.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: smiths medical portex low dead space connector with sideport the united states food and drug administration (fda) has issued a medical device safety alert concerning portex low dead space connector with sideport [product reorder no.: 10035-05ps; lot no.: 2553426], manufactured by smiths medical asd, inc. the affected products were distributed in november 2013. one lot of 3.0mm sized connectors, product reorder no. 10035-05ps, lot 2553426 were placed in packages labeled as 3.5mm. affected users are advised to examine their inventory and remove all affected products. for details, please refer to the following fda website:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm400982.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 june 2014.

Device

Portex Low Dead Space Connector with Sideport
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Smiths Medical Portex Low Dead Space Connector with Sideport
  • Manufacturer
    Smiths Medical ASD

Manufacturer

Smiths Medical ASD