Notificaciones De Seguridad De Campo acerca de Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por N/A.

¿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
    Field Safety Notice
  • Fecha
    2009-04-02
  • País del evento
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The mhra in the united kingdom have issued a medical device alert (mda/2009/021) concerning counterfeit novofine 31g insulin pen needles, 0.25m x 6mm in circulation in the united kingdom.  it is highly unlikely that the counterfeit needles have been manufactured to the appropriate standards.  the insulin used including the pen injection device is not affected.   to date, there is no evidence that these counterfeit products have been placed on the irish market.  lot number 08j02s is the only affected lot number.  there is no genuine product on the irish market with the same lot number.    as a precautionary measure, the imb are requesting that consumers and pharmacies check the lot number on the protective tab for the needle and on the carton label for the affected lot number.    the imb are advising pharmacies to examine their stock and immediately cease sales of lot number 08j02s.    should consumers have any of the counterfeit needles, the imb advise consumers to return any affected product to their local pharmacy and those with health concerns should consult with their general practitioner.   please notify the imb immediately if you have any novofine needles 31g, 0.25m x 6mm, lot number 08j02s.   the imb will continue to monitor this issue closely along with our colleagues in the united kingdom.

Device

  • Modelo / Serial
  • Descripción del producto
    Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA