Events

Alerte De Sécurité sur Xcela Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) Valve Technology / Kits and BioFlo PICC with Endexo and PASV Valve Technology / Kits

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Navilyst Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-01-07
  • Date de publication de l'événement
    2015-01-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150107.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: navilyst medical xcela peripherally inserted central catheter (picc) with pressure-activated safety valve (pasv) valve technology / kits and bioflo picc with endexo and pasv valve technology / kits medical device manufacturer, navilyst medical, inc., has issued a medical device recall concerning xcela peripherally inserted central catheter (picc) with pressure-activated safety valve (pasv) valve technology / kits and bioflo picc with endexo and pasv valve technology / kits. the manufacture is recalling picc that contain valve(s) manufactured prior to 9 october 2013. valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of haemolysis during blood sampling through the picc. according to the manufacturer, use of the affected products may have an increased incidence of haemolyzed blood samples which may require additional peripheral access or replacement of the picc. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 january 2015.

Device

Xcela Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) V...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Navilyst Medical Xcela Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) Valve Technology / Kits and BioFlo PICC with Endexo and PASV Valve Technology / Kits
  • Manufacturer
    Navilyst Medical

Manufacturer

Navilyst Medical