Events

Retiro De Equipo (Recall) de Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-00350-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-10
  • 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-00350-1
  • 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
    The manufacturer has received six reports where an open seal of the immediate packaging of devices was identified by customers. this open seal has the potential to compromise the sterility of the device(s). to date, no reports have been received in australia.The packaging for the affected product codes were found to have an opening in the seal which maintains the sterility of the device. the issue of the packaging failure is visually obvious.
  • Acción
    Customers are advised to discontinue use of the identified codes for the affected lot numbers. Contact BD to return and if required arrange a replacement or credit.

Device

Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow
  • Modelo / Serial
    Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow Thoracentesis/paracentesis kit 10/CS - TPK1001 Lot No. (LN): 0000851185, 0000840336, 0000842215, 0000837811Illinois (TJ) needle aspiration - TIN3015, TIN3018LN: 0000841213, 0000848061, 0000841215, 0000841212, 0000852078Jamshidi (TJ) needle bone marrow - TJM4011, TJC6011, TJC3513, TJC4011 LN: 0000852932, 0000843076, 0000853878, 0000841124, 0000851431, 0000850937 ARTG: 120894, 120890, 120892
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd