Events

Retiro De Equipo (Recall) de Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Injectable, Single-Chamber SystemsVital-Port Vascular Access System, Standard, Petite and Mini, Titanium and MRI, Single-Chamber SystemsVital-Port Vascular Access System, Standard and Petite Titanium, Dual-Chamber Systems

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-2017-RN-01453-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-11-29
  • 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-2017-RN-01453-1
  • 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
    During testing of the non-coring needle, cook medical have identified that the non-coring needle provided with the cook vital-port vascular assess system (vital-port) may cut or dislodge a core or sliver of material from the vital-port septum when the non-coring needle is inserted into the vital-port. this needle is used on the initial implant of the vital-port. vital-port products that have been successfully placed in patients are not impacted by this recall. there have been no adverse event reports from septum leakage or a silicone sliver pushed into the patient associated with these products to date.
  • Acción
    Cook Medical is advising users to inspect stock and quarantine any remaining units of the affected products for return.

Device

Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Inje...
  • Modelo / Serial
    Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Injectable, Single-Chamber SystemsVital-Port Vascular Access System, Standard, Petite and Mini, Titanium and MRI, Single-Chamber SystemsVital-Port Vascular Access System, Standard and Petite Titanium, Dual-Chamber SystemsMultiple catalogue numbers affectedAll lots are affectedARTG Numbers: 142612, 161948, 145710, 142851
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd