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 Atrium Medical Corporation.

¿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 039 10 18 000
  • Fecha de inicio del evento
    2018-10-11
  • 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=13290
  • 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
    This letter is intended to provide clarification about the current packaging configuration of the atrium ocean, oasis, express and express mini chest drainage products. atrium chest drainage products are packaged with a double sequential sterile wrap and placed into an outer dust cover. the dust cover is folded over and secured with the package label. this packaging system is the same configuration used on atrium chest drainage products for the past 30 years. this field notification is to provide clarification as to which part of the packaged drain is sterile. the label on the outer package denotes the product as being sterile. the chest drain inside the packaging is sterile; the outer dust cover is not sterile. the two sterilization wraps are what provide the sterile barrier for the product.

Device

ATRIUM OCEAN, OASIS, EXPRESS and EXPRESS MINI CHEST DRAINS
  • Modelo / Serial
    All Lot Numbers With Expiration Date Prior To October 2019
  • Descripción del producto
    Water Seal Chest Drain
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Representante del fabricante
    Gulf Medical Co.
  • Source
    SFDA