Events

Alerta De Seguridad O Notificaciones De Seguridad para Adaptors for Shelfpak humidifier and Aquapak sterile water

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom 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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/023
  • Número del evento
    CON426887
  • Fecha
    2014-06-17
  • Fecha de publicación del evento
    2014-06-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON426887?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    The packaging of these devices might not be sealed properly. however, the adaptors are used as part of a non-sterile system, so there is limited risk to patients. teleflex published a field safety notice recalling affected products in april 2014 but has not had sufficient confirmation from users that they have received and acted upon this information.
  • Acción
    Identify the affected devices using the FSN and quarantine them. Return affected devices and arrange for replacements from Teleflex. Return the acknowledgement form to the manufacturer. Action by: All staff who use these devices.

Device

Adaptors for Shelfpak humidifier and Aquapak sterile water
  • Modelo / Serial
  • Descripción del producto
    Adaptors for Shelfpak humidifier and Aquapak sterile water. Specific product and lot numbers. The adaptors may be sold separately or with the Aquapak sterile water.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical