Events

Retiro De Equipo (Recall) de Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/Kits

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00036-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00036-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia