Alerta De Seguridad para Hudson RCI Pediatric Anaesthesia Breathing Circuits

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

¿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
    2014-10-08
  • Fecha de publicación del evento
    2014-10-08
  • 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: teleflex medical hudson rci pediatric anaesthesia breathing circuits the united states food and drug administration (fda) issued a medical device safety alert concerning hudson rci pediatric anaesthesia breathing circuits, manufactured by teleflex medical. the affected products were manufactured from march 2013 to july 2014 and distributed from june 2013 to may 2014. according to the fda, the ends of the devices may crack or break before or during use. this could cause serious health risks, including delayed patient treatment and breathing difficulties if not replaced immediately. use of this device may also cause death. on september 8, 2014, the manufacturer sent customers an urgent medical device recall letter explaining the device problem and actions to be taken. the manufacturer recommends the following actions:- stop using the devices. remove the devices from inventory and stop distribution. for details, please refer to the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm417868.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm417731.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 october 2014.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Medical Device Safety Alert: Teleflex Medical Hudson RCI Pediatric Anaesthesia Breathing Circuits
  • Manufacturer

Manufacturer