Alerta De Seguridad para Filling Cannula

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

¿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
    2016-06-20
  • Fecha de publicación del evento
    2016-06-20
  • 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: inex filling cannula medical device manufacturer, inex, has issued a medical device safety alert concerning its micro cannula for filler injection. the affected devices are identified as follows:- a) filling cannula 25g x 50mm [reference number: mi2550kr; lot number: 013542] b) filling cannula 27g x 40mm [reference number: mi2740kr; lot number: 013520] following a complaint about one of their devices, the manufacturer is voluntarily recalling a batch of cannula to perform tests that determine whether a defect exists. the manufacturer has found that the hub of the cannula is difficult to connect at the syringe. 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 20 june 2016.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: INEX Filling Cannula
  • Manufacturer

Manufacturer

  • Source
    DH