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 Kimal plc.

¿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 026 05 15 001
  • Fecha de inicio del evento
    2015-06-03
  • 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=7732
  • 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, MHRA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The light glove may contain splits or holes or be torn.

Device

Devon Light Glove included in various Kimal Procedure Packs
  • Modelo / Serial
    Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380/P1 Product Description: KFMC PAEDIATRIC PACK Product Code: SA-K41949/P1 Product Description: KKNGH CARDIOLOGY PACING PACK Product Code: SA-K42117 Product Description: KKNGH REVEAL PACK Product Code: SA-K42118 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K43714 Product Description: CAESARIAN-SECTION PACK PSCC Product Code: SPR/9911/45035 Product Description: KFNGH PAEDIATRIC CATH LAB PACK Product Code: SPR/9964/41494 Product Description: KFNGH ADULT CATH LAB PACK Product Code: SPR/9964/41495 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42508 Product Description: KKUH PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42865 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/43714 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/45033 Lot Numbers : Please see attached ..................... MHRA update code Multiple products and Lot numbers of the affected device are provided in the attached FSN.
  • Descripción del producto
    This product is a disposable cover used in operating rooms
  • Manufacturer
    Kimal plc

Manufacturer

Kimal plc