Events

Rappel de Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/Kits

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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
    RC-2015-RN-00036-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00036-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Navilyst medical is recalling picc catheters that contain valve(s) manufactured prior to october 9, 2013. use of these picc catheters may have an increased incidence of hemolyzed blood samples which may require additional peripheral access or replacement of the picc catheter.Valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the picc catheter and they are not subject to this recall action.Types of tests affected include blood chemistries such as electrolytes and blood count measurements such as hemoglobin and hematocrit as they can be altered by hemolysis.To date, no patient injuries have been reported to navilyst medical as a result of this issue.
  • Action
    Customers are asked to inspect and quarantine affected stock for return to Navilyst Medical as per the directions in the Customer Letter. This action has been closed-out on 18/07/2016.

Device

Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/Kits
  • Modèle / numéro de série
    Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/KitsMultiple lot numbersARTG numbers: 175080, 178780 & 203831
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia