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 DeRoyal Industries Inc..

¿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 138 07 16 000
  • Fecha de inicio del evento
    2016-07-21
  • 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=9722
  • 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
    The issue reported and confirmed is that the product labeling for this lot states the product lot is sterile, however there is also a statement on the product labeling which states "non-sterile". the product is mislabeled, the error is that the product labeling states "non-sterile". upon investigation of this report, deroyal confirmed that this product, isolation bag 30-5510, is required to be sterilized with ethylene oxide gas during the operational processes at deroyal prior to release.

Device

DeRoyal Isolation Bag
  • Modelo / Serial
    The lot affected was manufactured on production work order 14097259
  • Descripción del producto
    Descriptor- lntraoperative Procedure Bag
  • Manufacturer
    DeRoyal Industries Inc.

Manufacturer

DeRoyal Industries Inc.