Events

Alerta De Seguridad para 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

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Navilyst Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-01-07
  • Fecha de publicación del evento
    2015-01-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150107.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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...
  • Modelo / Serial
  • Descripción del producto
    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