Events

Rappel de BIOFLO PICC IR-145 KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par NAVILYST MEDICAL INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    107810
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-04-04
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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:
  • Description du dispositif
    BioFlo PICC with Endexo and PASV Valve Technology IR-145 Kit
  • Manufacturer
    NAVILYST MEDICAL INC.

Manufacturer

NAVILYST MEDICAL INC.
  • Adresse du fabricant
    MARLBOROUGH
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    HC