Events

Alerta De Seguridad O Notificaciones De Seguridad para Various Arrow Critical Care devices

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.

¿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
    2018-05-31
  • Fecha de publicación del evento
    2018-05-31
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/various-arrow-critical-care-devices-recall-due-to-incomplete-packaging-seals
  • 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 teleflex – various critical care devices manufactured from january to december 2017 inclusive have been placed on the market with incomplete packaging seals potentially leading to infection.
  • Acción
    Refer to the manufacturer’s FSN for a list of affected products Identify, cease using and quarantine these devices Contact Arrow International to return the devices

Device

Various Arrow Critical Care devices
  • Modelo / Serial
  • Descripción del producto
    Please refer to the FSN and related Appendix for a complete list of affected products. Note that Devices marked as non-CE marked are not on the EU market.In addition to the Field Safety Notice which details affected product, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information.
  • Manufacturer
    Teleflex

Manufacturer

Teleflex
  • Dirección del fabricante
    Ken Oshanksy Arrow International Inc. 4024 Stirrup Creek Drive NC 27703 Durham USA Tel: +1 919-433-4940Email: internationalFCA@teleflex.comCliodhna Coffey UK Customer Service Fax: +44 (0) 1494 524650 Tel: +44 (0) 1494 532761Email: orders.uk@teleflex.com
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    MHRA