Events

Retiro De Equipo (Recall) de COBE TRIMA BLOOD COLLECTION SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TERUMO BCT (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
    132630
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-02-08
  • 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
    Defects may occur during the manufacturing of trima accel tubing sets. it was found during assembly of the ac/draw/return manifold the automated equipment may improperly insert the return line tubing into the manifold in such a way that the tubing maybe bent.

Device

COBE TRIMA BLOOD COLLECTION SYSTEM
  • Modelo / Serial
    Model Catalog: 80700 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80450 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80500 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80490 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 777800-450 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80449 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80440 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80400 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 777800-550 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 777800-500 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 777800-400 (Lot serial: CONTACT MANUFACTURER FOR LOTS); Model Catalog: 80550 (Lot serial: CONTACT MANUFACTURER FOR LOTS)
  • Descripción del producto
    COBE TRIMA BLOOD COLLECTION SYSTEM
  • Manufacturer
    TERUMO BCT (CANADA) INC.

Manufacturer

TERUMO BCT (CANADA) INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    HC