Events

Alerta De Seguridad O Notificaciones De Seguridad para Rusch Belly Bag urine collection bag with hip belt

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/2013/038
  • Número del evento
    CON286861
  • Fecha
    2013-06-12
  • Fecha de publicación del evento
    2013-06-12
  • 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/CON286861?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
    Packaging may be compromised and therefore the sterility of the product cannot be guaranteed. if non-sterile products are used, there is a risk of infection.
  • Acción
    Identify and quarantine affected products. Contact patients who have received affected stock and retrieve any unused devices. Teleflex Medical issued a Field Safety Notice (FSN) on 27 March 2013 recalling all batches of the affected product codes. Return the acknowledgement form to Teleflex and arrange for the return and replacement of unused affected devices. Personnel involved in the purchase, supply and distribution of these devices.

Device

Rusch Belly Bag urine collection bag with hip belt
  • Modelo / Serial
  • Descripción del producto
    Rusch Belly Bag urine collection bag with hip belt. Specific product codes. All lot numbers of the following product codes are affected: Belly Bag, product code B1000 (NHS Supply Chain code GDW502) Belly Bag with 24 inch drain, product code B1000CT Belly Bag with sample port, product code B1000P
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical