Events

Notificaciones De Seguridad De Campo acerca de AidFast, 1st Aid & Powerplast Digital Thermometers

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
  • Número del evento
    SN2009(03)
  • Fecha
    2009-04-23
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/aidfast-1st-aid-powerplast-digital-thermometers&id=2d93f825-9782-6eee-9b55-ff00008c97d0
  • 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
    Non-compliant and inaccurate (up to 0.5°c) aid fast, 1st aid and powerplast digital thermometers have been provided to discount outlets in ireland.  these digital thermometers are not appropriately ce marked.  these thermometers may be marketed under a variety of brands and the packaging may vary.
  • Acción
    Advice for Pharmacies, Retailers and Wholesalers  Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices branded Aid Fast, 1st Aid or Powerplast digital thermometers.   If you find that you have these products cease sale of these products immediately and quarantine all stock.  Contact the IMB immediately to obtain further instruction and guidance.   Also, should you discover any other similar brands of digital thermometers that do not clearly identify the manufacturers name and address on the packaging, please advise the IMB.   Advice for Consumers Consumers should check their digital thermometer to determine if their device is branded Aid Fast, 1st Aid or Powerplast.   If you find that you have one of these devices, discontinue use immediately and seek an alternative.  Consumers with health concerns should consult with their general practitioner.

Device

AidFast, 1st Aid & Powerplast Digital Thermometers
  • Modelo / Serial
  • Descripción del producto
    AidFast, 1st Aid & Powerplast Digital Thermometers
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA