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 Advanced Sterilization Products.

¿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 016 05 12 000
  • Fecha de inicio del evento
    2012-05-06
  • 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=1797
  • 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 applies to all lots of glosair™ 400 cartridges (cartridges) shipped within the past year that indicate a storage temperature of 5º - 40ºc. asp has recently determined that the cartridges, if stored at the upper extreme of the permitted labeled temperature requirements, may not meet product specifications for end of shelf life. while you can be assured that this presents no health risk, in keeping with our commitment to provide customers with quality products, asp has voluntarily decided to recall the product, and will be correcting future product to reflect the appropriate storage conditions and shelf life.

Device

Cleaning, GLOSAIR™ 400 Cartridges

Manufacturer

Advanced Sterilization Products
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Representante del fabricante
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (01) 4142200
  • Source
    SFDA