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 Lifetech Scientific (Shenzhen) Co., Ltd..

¿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 137 10 18 000
  • Fecha de inicio del evento
    2018-10-24
  • 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=13392
  • 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: BfArM
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Lifetech states that the size of the loader of the above systems may be too small, potentially causing difficulty for the matching delivery cable to pass through. lifetech also states that this problem can be noticed during pre-operative preparation, and that potential hazards include a delay in procedure and the need to replace the loader. lifetech further states that this problem occurs because the inner diameter of the loader did not reach its lower limit, which was caused by the manufacturing process problem of the supplier.

Device

Cera Vascular Plug Systems
  • Modelo / Serial
    LT-PLUG-04 1721010410180107211801070372, 1721010410180107211801070373, 1721010410180107211801070374, 1721010410180107211801070375, 1721010410180107211801070376, 172101041018010721801070377 180107 LT-PLUG-04 1721011810180134211801340251, 172101181018013421801340252, 1721011810180134211801340253, 1721011810180134211801340254, 1721011810180134211801340255, 1721011810180134211801340256, 1721011810180134211801340258, 1721011810180134211801340259, 1721011810180134211801340260 180134 LT-PLUG-06 1720122710171252211712521320, 1720122710171252211712521321, 1720122710171252211712521322, 1720122710171252211712521323, 1720122710171252211712521327, 1720122710171252211712521328, 1720122710171252211712521329, 1720122710171252211712521330 171252 LT-PLUG-06 1721010410180107211801070384, 1721010410180107211801070385, 1721010410180107211801070386, 1721010410180107211801070387, 1721010410180107211801070388, 1721010410180107211801070389 180107 LT-PLUG-06 1721012410180146211801460777, 1721012410180146211801460778, 1721012410180146211801460779 180146 LT-PLUG-06 1720122710171252211712521325, 1720122710171252211712521324 171252 LT-PLUG-06 1721012410180146211801460780, 172101241018014621801460781 180146
  • Descripción del producto
    Vascular Closure Devices
  • Manufacturer
    Lifetech Scientific (Shenzhen) Co., Ltd.

Manufacturer

Lifetech Scientific (Shenzhen) Co., Ltd.