Events

Rappel de Suction Tube

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ConvaTec 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-00514-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-17
  • 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-00514-1
  • 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
    An internal assessment of product complaints has confirmed that these devices are not meeting the manufacturer's specifications. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Action
    Convatec is requesting end users to quarantine the affected product and return to their distributor for replacement or credit. This action has been closed-out on 11/08/2016.

Device

Suction Tube
  • Modèle / numéro de série
    Suction TubeSterile Codes: 530.25.200, 530.25.300, 530.25.450, 530.25.600, 530.25.800, 530.30.200, 530.30.300, 530.30.450, 530.30.600, 533.30.300Non-sterile Codes: 533.25.050, 533.25.100, 533.25.150, 533.25.200, 533.25.300, 533.25.450, 533.25.600Multiple BatchesARTG Numbers: 173916 (Sterile) & 204281 (Non-sterile)
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd