Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Stryker.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 028 11 15 000
  • Fecha de inicio del evento
    2015-11-08
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8458
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    It was identified by a customer complaint that some i.V. poles were retracting/lowering from an extended position to the low height unexpectedly. an investigation was initiated which identified that the i.V. latch housing was nonconforming.

Device

Stryker 2-Stage and 3-Stage I.V. Poles
  • Modelo / Serial
    Manufacturer Model Number # 2035-112-010 Product Description : Head End Left, 2 Stage I.V. Pole Manufacturer Model Number # 2035-113-011 Product Description : Head End Right, 2 Stage I.V. Pole Manufacturer Model Number # 0785-035-101 Product Description : 26", 2 Stage IV Pole Assembly Manufacturer Model Number # 0785-035-200 Product Description : 26", 3 Stage IV Pole Assembly Manufacturer Model Number # 0785-035-300 Product Description : 30", 3 Stage IV Pole Assembly Manufacturer Model Number # 0785-035-401 Product Description : 30", 2 Stage IV Pole Assembly For I.V. Pole option numbers ship as service kits. ( Please see attachment )
  • Descripción del producto
    Pop-up Push Handles, Surgical Accessory Rail
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Empresa matriz del fabricante (2017)
    Stryker
  • Representante del fabricante
    Al-Faisaliah Medical System
  • Source
    SFDA