Events

Alerta De Seguridad O Notificaciones De Seguridad para Receptal suction canisters and liners

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 Hospira (formerly manufactured by Abbott).

¿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/2013/077
  • Número del evento
    CON330878
  • Fecha
    2013-10-31
  • Fecha de publicación del evento
    2013-10-31
  • 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/CON330878?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
    Potential for failure or loss of suction if a canister and liner of different sizes are used in combination. due to a number of customer complaints, hospira has issued a field safety notice (dated 6 september 2013) to advise customers of appropriate use and combination of liners and canisters. the mhra is not confident that hospira has been able to reach all affected customers.
  • Acción
    Identify affected devices. Ensure that the correctly sized liner is used with the canister. Obtain a copy of the revised instructions for use from Hospira when this is made available. Use only Receptal liners with Receptal canisters in the following combinations: 1.5 litre liner with a 1.5 litre canister 2 litre liner with a 2 litre canister 3 litre liner with a 3 litre canister Please note that all 1 litre liners and canisters have been recalled. See MDA/2013/048 for further information.

Device

Receptal suction canisters and liners
  • Modelo / Serial
  • Descripción del producto
    Receptal suction canisters and liners. All Abbott and Hospira list numbers are affected. All lot numbers and sizes are affected. This is a closed, disposable system that is used to isolate suction waste. It is used with adult, paediatric and neonatal patients. Hospira has only been able to provide the Abbott list numbers for the 1 litre liners and canisters.
  • Manufacturer
    Hospira (formerly manufactured by Abbott)

Manufacturer

Hospira (formerly manufactured by Abbott)
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    MHRA