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 Vascutek Limited.

¿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 025 01 13 000
  • Fecha de inicio del evento
    2013-01-13
  • 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=5&rid=2858
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Vascutek has received a number of events involving graft bleeding including anastomotic bleeding and suture hole bleeding, either during or shortly after surgery.

Device

Vascular Grafts, Biplex vascular grafts and Biplex BioValsalva conduits
  • Modelo / Serial
    Catalogue Numbers: Biplex straight vascular grafts BL6006, BL6007,BL6008, BL6009, BL6010, BL6011, BL6012. BL6014.BL6016,BL4006, BL4008, BL3006, BL3007, BL3008, BL3009, BL3010, BL3011, BL3012, BL3014. 8L3016, Bl1506, BL1507, BL1508, BL1509, BL1510, BL1511, BL1512, BL1514, BL1516, BL5016.BL5018,BL5020j BL5022, BL5024, BL5026, Bl5028, BL5030, BL5032, BL5034, BL5036, BL5038, BL0526. BL0528, BL2518, BL2520, BL2522, BL2524, BL2526, BL2528, BL1218, BL1220, BL1222, BL1224, BL1226, BL1228. BL3018, BL3020, BL3022, BL3024, BL3026, BL3028, BL3030, BL3032, BL3034, BL3036, BL3038, BL1030, BL1032, BL1034, BL1036, Bl2030, BL2032, BL2034, BL2036, BL2038, BL4030, BL4032 Bt4034. BL4036, BL4038, BL6018, BL6020, BL6022, BL6024, BL6026, BL6028, BL6030, BL6032,BL6034. BL6036,BL6038 Biplex Valsalva vascular grafts BL0022ADP, BL0024ADP, BL0026ADP, BLO028ADP, BL0030ADP, BL0032ADP, Bl0034ADP Biplex Biovalsalva Conduit (stentless) EHVC21, EHVC23, EHVC25. EHVC27 . Stented Biovalsalva ~()nduit (Biplex stQl"ited) AHVC25, AHVC27, AHVC29 Batch No: All batches Serial No: All serial numbers
  • Descripción del producto
    Synthetic vascular graft and cardiac valve graft/vascular prosthesis, animal derived
  • Manufacturer
    Vascutek Limited

Manufacturer

Vascutek Limited
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Representante del fabricante
    Gulf Medical Co., (012) 6512828
  • Source
    SFDA