Events

Alerta De Seguridad O Notificaciones De Seguridad para Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retractable needle insulin

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Medicina 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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/033
  • Número del evento
    CON448008
  • Fecha
    2014-08-20
  • Fecha de publicación del evento
    2014-08-20
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON448008?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    The affected devices are unable to deliver fewer than 7 units of insulin. in addition, the safety and performance of these devices has not been properly evaluated and so the ce marking of all of these devices is invalid. medicina issued a field safety notice in june 2014 but has not had sufficient confirmation that customers have received and acted on these notices.
  • Acción
    Do not use affected devices. Quarantine them and contact Medicina Ltd to arrange for their collection. Return the email / fax back form in the FSN to the manufacturer. Personnel involved in the purchase, supply and distribution of these devices.

Device

Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retract...
  • Modelo / Serial
  • Descripción del producto
    Insulin syringe 1ml safety syringe 27G (for professional use). Product code: RN01/27i. All batches. If relevant to you, the NHS Supply Chain Code is as follows: Medicina product code NPC Product description RN01/27i FWD150 Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retractable needle insulin
  • Manufacturer
    Medicina Ltd

Manufacturer

Medicina Ltd
  • Empresa matriz del fabricante (2017)
    Luan Srl
  • Source
    MHRA