Events

Rappel de 300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par KCI Medical Australia 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-01169-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-02
  • 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-01169-1
  • 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
    Internal testing has revealed the potential for small holes the size of a pin to develop in the pouches of the sterile canisters. if these small holes occur and the canister is used in a sterile field, there is a potential for contamination.To date, there have been no complaints regarding damaged packaging or reports of any patient injuries or complications due to potentially non-sterile canisters.
  • Action
    The sponsor is advising the users to inspect stock and quarantine the affected units prior to their return. Alternatively, users can continue to use the affected devices provided that the tubing cap remains in the tubing until use and the canister is used outside of the operating room's sterile field. This action has been closed-out on 26/08/2016.

Device

300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System
  • Modèle / numéro de série
    300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System Part number M8275059/5Lot Numbers: 2590876 (expiry date 11/2016) and 2590877 (expiry date 01/2017) ARTG Number: 226774
  • Manufacturer
    KCI Medical Australia Pty Ltd

Manufacturer

KCI Medical Australia Pty Ltd