Events

Retiro De Equipo (Recall) de Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & Trays Femoral Artery Pressure Monitoring Catheter Sets & Trays Radial Artery Pressure Monitoring Catheter Sets & Trays

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia Pty Ltd.

¿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-2016-RN-00052-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-01-14
  • 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-2016-RN-00052-1
  • 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
    Certain central venous catheters and pressure monitoring sets are being recalled due to an issue being identified with a manufacturing process that could result in the potential for catheter tip fracture and/or separation. potential adverse events that may occur as a result of catheter tip fracture and or separation may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. there have been no reports of illness or injury associated with this issue.
  • Acción
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & T...
  • Modelo / Serial
    Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & TraysFemoral Artery Pressure Monitoring Catheter Sets & TraysRadial Artery Pressure Monitoring Catheter Sets & TraysReference Part Numbers (RPN): C-NPMS-501J-15, C-PMS-301-FA, C-PMS-301J-FA, C-PMS-301J-PED, C-PMS-301-RA, C-PMS-400-RA, C-PMS-401-FA and C-PMS-401J-FAMultiple Lot Numbers affectedARTG Numbers: 154878 and 156190
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd