Events

Notificaciones De Seguridad De Campo acerca de STERILE WINDING 18G

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Kimal Plc.

¿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
    2016-06-03
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Kimal received a complaint from one party that the above product was inconsistent when sealing the bag. after an internal inspection of the stored specimens, we identified some instances where the pouch was not sealed in the corner where it normally opens, meaning that the product is no longer sterile. we kindly ask you to review your stock of the above mentioned product and batch numbers. if you find that the bag is not sealed, remove the product in question from your stock and discard it. tell kimal how many products you have discarded and you will receive free replacement items. the photos below show a seal error and acceptable seal:.

Device

STERILE WINDING 18G

Manufacturer

Kimal Plc