Events

Alerta De Seguridad O Notificaciones De Seguridad para Basin/bowl liner or equipment cover (drape)

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 Microtek Medical.

¿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/2014/034
  • Número del evento
    CON448388
  • Fecha
    2014-08-27
  • Fecha de publicación del evento
    2014-08-27
  • 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/CON448388?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 manufacturer has found that some of these devices within the above product codes may have small cracks or holes. this could compromise the sterile field. the manufacturer issued a field safety notice (fsn) dated 14 july 2014 but hasn’t had enough confirmation that customers have received and acted on it.
  • Acción
    Identify affected devices as described in the FSN. Remove and quarantine any affected stock and return to Microtek Medical. Complete the response form and return it to Microtek Medical.

Device

Basin/bowl liner or equipment cover (drape)
  • Modelo / Serial
  • Descripción del producto
    Basin/bowl liner or equipment cover (drape). Product codes: 17700, 16700A, 3109N, 3109NT, 3108N, 33099, 9386001, 3309N, TP1909A, TP1909B. All lot numbers. These products (a type of surgical drape) are manufactured by Microtek Medical, but may be distributed by other companies. These devices will have been supplied in procedure packs. See page 5 of the manufacturer’s FSN for full product descriptions. All devices manufactured since August 2009 are affected by this recall.
  • Manufacturer
    Microtek Medical

Manufacturer

Microtek Medical
  • Empresa matriz del fabricante (2017)
    Ecolab Inc
  • Source
    MHRA