Events

Rappel de ARCTICGEL Pads (used with the Arctic Sun Temperature Management 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 Bard 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-2016-RN-00234-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-03
  • 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-2016-RN-00234-1
  • 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
    Bard medical division (bmd) has received complaint reports of low flows associated with certain lots of the arcticgel pads. the clinical risk associated with the restricted/low flow arcticgel pads is suboptimal therapy delivery. in the event that one or more arcticgel pads do not have sufficient flow, the arcticgel pads may need to be exchanged. this may result in a slight delay in the therapy delivery which, if done in a timely manner, is not associated with long-term or residual clinical consequences. if alternate pads are not available, the patient may require therapy delivery by alternate means.
  • Action
    Bard is advising users to inspect stock for the affected lot numbers. Any remaining affected product can be returned. This action has been closed-out on 30/01/2017.

Device

ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)
  • Modèle / numéro de série
    ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)Multiple Product Codes and Lot Numbers affectedARTG Number: 262560
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd