Events

Notificaciones De Seguridad De Campo acerca de ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Droppe

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

¿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
    SN2011(10)
  • Fecha
    2011-06-01
  • 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=/acu-life-dosage-spoon-acu-life-dosage-dropper&id=9d85f825-9782-6eee-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 acu-life dosage spoons and acu-life dosage droppers have been provided to pharmacy outlets in ireland. these dosage spoons and dosage droppers are not appropriately ce marked. although they carry the ce mark, the ce mark is not accompanied by a four digit notified body number, which confirms that the measuring function aspect of the medical device has been reviewed and certified by a notified body, as required by the medical devices legislation.
  • Acción
    Advice for Pharmacies  Pharmacies and retailers should examine their stock to determine if they have any ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.  If you find that you have these products, cease sale of these products immediately and quarantine all stock and contact Atlantico Systems immediately to obtain further instruction and guidance.  Please advise the IMB should you discover any other similar brands of dosage spoons, dosage droppers or medicines feeders that:  (a) Do not carry the CE mark  (b) Carries a CE mark but the CE mark is not accompanied by a four digit Notified Body number  Advice for Consumers  Consumers should check their dosage spoons and/or dosage droppers to determine if their device is branded ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.  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

ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Droppe
  • Modelo / Serial
  • Descripción del producto
    ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Dropper
  • Manufacturer
    Health Enterprises Inc.

Manufacturer

Health Enterprises Inc.