Events

Retiro De Equipo (Recall) de BD VACUTAINER PLUS PLASTIC CITRATE TUBES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECTON DICKINSON 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
    71753
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-11-26
  • 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
    There is evidence that in a portion of the affected lot there is a cross-contamination with lithium heparin in a concentration not exceeding 1.2 iu per milliliter in plasma obtained from properly filled tubes (note: this value was obtained from healthy subjects using a limited number of tubes from the affected lot). the internal investigation completed by bd indicates that this contaminant can adversely affect coagulation results. erroneous results may lead to inappropriate decisions regarding patient care. for a full listing of assays that may be adversely affected by the lithium heparin contaminant please contact the manufacturer.

Device

BD VACUTAINER PLUS PLASTIC CITRATE TUBES
  • Modelo / Serial
    Model Catalog: 363083 (Lot serial: 2180434)
  • Descripción del producto
    BD Vacutainer Plus 2.7mL Citrate Blood Collection Tube
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.