Events

Alerta De Seguridad O Notificaciones De Seguridad para Safety blood collection and infusion sets

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 Greiner Bio-One.

¿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/2013/047
  • Número del evento
    CON287019
  • Fecha
    2013-06-27
  • Fecha de publicación del evento
    2013-06-27
  • 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/CON287019?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
    Risk of leakage of blood or infusion fluid, or under-filling of evacuated blood collection tubes or blood culture bottles. this product is being recalled due to potential cracking of the luer connector on these devices.
  • Acción
    Identify and quarantine affected products. Greiner Bio-One issued a Field Safety Notice (FSN) in March 2013 recalling affected products. Confirm receipt of the FSN to Greiner Bio-One and arrange for the return and replacement of unused affected devices.

Device

Safety blood collection and infusion sets
  • Modelo / Serial
  • Descripción del producto
    Safety blood collection and infusion sets. Various item and lot numbers. The affected devices are illustrated below.  The area where the crack may occur is circled.  A list of the affected item codes and lot numbers are provided in the FSN .  The NHS Supply Chain codes (England only) corresponding to the manufacturer’s item codes are given as below. Safety infusion sets Greiner Bio-One code NHS supply chain code LOT numbers 450092 KFK 024 12H23 Safety blood collection sets with Luer adapter Greiner Bio-One code NHS supply chain code LOT numbers 450081 KFK 134 12H23, 12H24, 12I17, 12I26, 12H30 450082 KFK 136 12H21, 12H22, 12H30 450083 none 12I16 450084 none 12H29 450095 KFK 302 12H19, 12I22 450099 none 12H26 Safety blood collection sets with Luer adapter and holder Greiner Bio-One code NHS supply chain code LOT Numbers 450086 KFK 138 12H28, 12H25, 12H27, 12I26, 12I24, 12I25 Safety blood collection sets with blood culture holder Greiner Bio-One code NHS supply chain code LOT Numbers 450182 KFK 416 12H21, 12H30, 450184 KFK 418 12H22, 12H23, 450185 KFK 419 12H24, 12H23, 12I20
  • Manufacturer
    Greiner Bio-One

Manufacturer

Greiner Bio-One