Events

Retiro De Equipo (Recall) de Codan Extension Set With SAFTI-JECT SV Swabable Valve Needleless Connector And a Back Check Valve - 28 cm. (Tubing to extend the length of an IV administration set)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por REM Systems 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-2015-RN-00309-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-04-22
  • 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-00309-1
  • 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
    Rem systems have received reports where the extension set has been used with pressure injectors. this set is not designed to be used with pressure injectors. the instructions for use (ifu) have been updated to include a statement indicating that the extension set should not be used with pressure injectors.
  • Acción
    The new IFU is attached with the customer letter and REM systems is requesting the users to replace the existing IFU with the updated IFU. This action has been closed-out on 06/09/2016.

Device

Codan Extension Set With SAFTI-JECT SV Swabable Valve Needleless Connector And a Back Check Valve...
  • Modelo / Serial
    Codan Extension Set With SAFTI-JECT SV Swabable Valve Needleless Connector And a Back Check Valve - 28 cm. (Tubing to extend the length of an IV administration set)Catalogue Number : BC 7034All batch numbersARTG number: 126685
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd