Events

Rappel de ARROW VASCULAR POSITIONING SYSTEM (VPS) - BEDSIDE PROCEDURE KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TELEFLEX MEDICAL CANADA 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
    67749
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-08-13
  • 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
    Arrow is recalling certain lots of the products referenced above due to reports clinicians have had difficulty maintaining a secure connection between the male luer of the tuohy borst adapter of the vascular positioning system stylet to the hub of the catheter. when the connection is not secure there is a possibility the connection will leak saline. this is most often discovered during initial flushing prior to insertion in which case a delay in treatment can occur while the health care provider locates a replacement device. in the unlikely event that the issue is discovered while the device is in use it could result in an inability to obtain a signal on the vps console. this would in turn necessitate removal and replacement of the catheter or an x-ray to confirm proper catheter placement.

Device

ARROW VASCULAR POSITIONING SYSTEM (VPS) - BEDSIDE PROCEDURE KIT
  • Modèle / numéro de série
    Model Catalog: VPS7220B (Lot serial: > 10 numbers contact mfg)
  • Description du dispositif
    ARROW INTERNATIONAL VPS ACCESS KIT WITH TUOHY BORST COMPONENT
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.