Events

Retiro De Equipo (Recall) de OPTIFLUX HEMODIALYZERS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por FRESENIUS MEDICAL CARE CANADA INC..

¿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
    68678
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-01-27
  • 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
    Two lots of f25onre dialyzer were recalled in february 2011 (incident id 61779) due to increased complaints associated with internal blood leaks. quality trending revealed that lot 10hu02012 and 10lu02016 demonstrated a higher blood leak rate than for other lots. following a fda inspection a decision was made by the legal manufacturer to place addition 20 lots as they were manufactured under the same production process and could not be definitively segregated from the recalled lots.

Device

OPTIFLUX HEMODIALYZERS
  • Modelo / Serial
    Model Catalog: 0500325E (Lot serial: 8SU205); Model Catalog: 0500325E (Lot serial: 8SU204); Model Catalog: 0500325E (Lot serial: 09DU02014); Model Catalog: 0500325E (Lot serial: 09DU02013); Model Catalog: 0500325E (Lot serial: 09DU02022); Model Catalog: 0500325E (Lot serial: 09NU02011); Model Catalog: 0500325E (Lot serial: 09PU02011); Model Catalog: 0500325E (Lot serial: 8SU203); Model Catalog: 0500325E (Lot serial: 10LU02015); Model Catalog: 0500325E (Lot serial: 10LU02014); Model Catalog: 0500325E (Lot serial: 10LU02013); Model Catalog: 0500325E (Lot serial: 10LU02001); Model Catalog: 0500325E (Lot serial: 10HU02014); Model Catalog: 0500325E (Lot serial: 10HU02013); Model Catalog: 0500325E (Lot serial: 10EU02017); Model Catalog: 0500325E (Lot serial: 10EU02010); Model Catalog: 0500325E (Lot serial: 10CU02001); Model Catalog: 0500325E (Lot serial: 10AU02013); Model Catalog: 0500325E (Lot serial: 09SU02007); Model Catalog: 0500325E (Lot serial: 09SU02001)
  • Descripción del producto
    OPTIFLUX HEMODIALYZERS (F250NR)
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.