Events

Retiro De Equipo (Recall) de BIOFLO PICC IR-145 KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por NAVILYST MEDICAL 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
    107810
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-04
  • 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
    Navilyst medical is recalling picc catheters that contain valve(s) manufactured prior to july 15 2014. valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the picc catheter. use of the picc catheters that are subject to this recall may result in an increased incidence of hemolyzed blood samples which may require additional peripheral access or replacement of the picc catheter.

Device

BIOFLO PICC IR-145 KIT
  • Modelo / Serial
    Model Catalog: H965458840 (Lot serial: lot # 4830558); Model Catalog: H965458840 (Lot serial: lot # 4819459); Model Catalog: H965458840 (Lot serial: lot # 4797578); Model Catalog: H965458840 (Lot serial: lot # 4776149); Model Catalog: H965458840 (Lot serial: lot # 4753201); Model Catalog: H965952420 (Lot serial: > 10 numbers contact mfg); Model Catalog: H965952430 (Lot serial: > 10 numbers contact mfg); Model Catalog: H965952460 (Lot serial: > 10 numbers contact mfg); Model Catalog: H965952470 (Lot serial: > 10 numbers contact mfg); Model Catalog: M001454730 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454590 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454740 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454640 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454790 (Lot serial: >10 numbers contact mfg); Model Catalog: M001454580 (Lot serial: >10 numbers contact mfg); Model Catalog: H965458410 (Lot serial: lot # 4814218); Model Catalog: H965458410 (Lot serial:
  • Descripción del producto
    BioFlo PICC with Endexo and PASV Valve Technology IR-145 Kit
  • Manufacturer
    NAVILYST MEDICAL INC.

Manufacturer

NAVILYST MEDICAL INC.
  • Dirección del fabricante
    MARLBOROUGH
  • Empresa matriz del fabricante (2017)
    AngioDynamics Inc
  • Source
    HC