Events

Retiro De Equipo (Recall) de POLYFLUX REVACLEAR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAXTER CORPORATION.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    148834
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2016-10-05
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Baxter corporation is issuing a voluntary product recall for one (1) lot of revaclear max dialyzers due to the potential presence of particulate matter within the blood side of the dialyzer. the issue was identified as a result of one customer complaint received for the presence of black fibers and dust within the dialyzer. there is the potential of visually not detecting the presence of foreign material in the blood side of the dialyzer. when the dialyzer is used the particles may become dislodged by flow of the dialysate and may reach the vascular system of the patient which could lead to adverse health consequences. there have been no reports of injuries associated with this issue.

Device

POLYFLUX REVACLEAR

Manufacturer

BAXTER CORPORATION