Events

Alerta De Seguridad O Notificaciones De Seguridad para Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags

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 ConvaTec Limited.

¿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
  • Fecha
    2018-11-14
  • Fecha de publicación del evento
    2018-11-14
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/suction-catheters-gastro-enteral-tubes-intermittent-urology-catheters-and-sterile-urine-drainage-bags-potential-breach-in-sterile-barrier-packaging-mda-2018-034
  • 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
    Manufactured by convatec limited – use of affected devices may increase risk of patients getting infections.
  • Acción
    Refer to the manufacturer’s Field Safety Notice FSN for a list of affected product codes and affected lots. Stop using and quarantine affected devices as directed in the manufacturer’s FSN. Complete the ‘Recall Response Form for END USERS’ in the FSN and return to convatecproductrecall@stericycle.com to arrange return of affected device(s). Report any incidents or complaints involving this product to unomedical-uk.customerservice@convatec.com.

Device

Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainag...
  • Modelo / Serial
  • Descripción del producto
    Affected devices can only be identified by comparing product code and manufacture date stated on the packaging to the product list in the manufacturer’s FSN. The breach in the packaging is not visible.In addition to the FSN, which details the affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information and national supply chain codes (where available).
  • Manufacturer
    ConvaTec Limited

Manufacturer

ConvaTec Limited
  • Dirección del fabricante
    ConvaTec Limited Tel: 01244 832206 Email: convatecproductrecall@stericycle.com, unomedical-uk.customerservice@convatec.com.
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    MHRA