Events

Rappel 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)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par REM Systems Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00309-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-04-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00309-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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