Events

Notificaciones De Seguridad De Campo acerca de Hudson RCI® Sheridan/CF® Cuffed Tracheal Tube

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Teleflex Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2014-11-14
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Teleflex medical is recalling the product referenced above due to a labelling inconsistency. teleflex medical has received complaints that the labelling of units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube. it is unlikely that the mislabelling will result in any serious adverse health consequences; however, it may cause difficulty in obtaining a proper seal between the device and the patient, possibly necessitating reintubation of the patient and resulting in a delay in treatment. teleflex medical is recalling the affected lot in an effort to provide our customers and their patients with the highest quality product possible.

Device

Hudson RCI® Sheridan/CF® Cuffed Tracheal Tube

Manufacturer

Teleflex Medical