Events

Notificaciones De Seguridad De Campo acerca de curettes (flexible and rigid), uterine dilators (e.g. Laminaria), endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, aspiration sets, biopsy pipettes, and harvesting pumps used in in-vitro fertilization

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por A & A 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
    Field Safety Notice
  • Número del evento
    SN2002(03)
  • Fecha
    2002-06-13
  • 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=/a-a-products&id=d19af825-9782-6eee-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
    Fda is alerting consumers and health care professionals of a nationwide/international recall of all medical devices labelled as sterile or ethylene oxide processed, manufactured by a&a of alpharetta, georgia.  the firm also does business as a&a medical/rocket usa, and lifequest.  some of the products manufactured by this company have been labelled and shipped as sterile but in fact may not have undergone any sterilization process.  this has the potential of causing death or serious injury such as infection, infertility, and miscarriage.  as a result, the company is recalling all products labelled as sterile and shipped nationwide and internationally to canada, egypt, italy and lebanon.
  • Acción
    Do not use any A & A Medical, Inc., Rocket USA, or Lifequest products. Please ensure that those responsible for the purchase of these devices are made aware of this issue.

Device

curettes (flexible and rigid), uterine dilators (e.g. Laminaria), endometrial sampling sets, feta...
  • Modelo / Serial
  • Descripción del producto
    A&A; Products
  • Manufacturer
    A & A Medical

Manufacturer

A & A Medical
  • Source
    HPRA