Events

Retiro De Equipo (Recall) de COMBINED OXYGEN AND TEMPERATURE PROBE

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

¿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
    52531
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-12-31
  • 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
    Integra lifesciences initiated a recall to remove all affected licox probes and probe kits that may contain an inaccurate smart cards supplied with the subject devices. the ikn2 value in approximately 90% of the potentially affected cards is approximately 10 times higher than it should be resulting in varying degrees of understated po2 values (from -1 mmhg to -7 mmhg) when the probes are used.

Device

COMBINED OXYGEN AND TEMPERATURE PROBE
  • Modelo / Serial
    Model Catalog: CC1.P1 (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: CC1.SB (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IP1.P (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IP2.P (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM3.ST (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM1.S (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM3.S (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IT2 (Lot serial: ALL LOT #'S SINCE OCT 1 2013)
  • Descripción del producto
    COMBINED OXYGEN AND TEMPERATURE PROBE
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.