Events

Rappel de Caliber Inflation Device

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-2017-RN-00758-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-13
  • 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-2017-RN-00758-1
  • 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
    The manufacturer, perouse medical has identified that specific product code / lot number combinations of the caliber inflation device may be at risk of containing a crack in the primary packaging, resulting in a breach of the sterile barrier. for a cracked package, there is the risk of microbial contamination (infection) caused by the use of a product. sterility would not be preserved due to a primary packaging damage.
  • Action
    Bard is advising users to immediately examine their inventory, and quarantine and remove product subject to this recall from their shelves. Do not use or further distribute any affected product. Product is to be returned by either handing to the user's Bard Territory Manager or by contacting Bard Australia Customer Service who will arrange for the return of any affected product.

Device

Caliber Inflation Device
  • Modèle / numéro de série
    Caliber Inflation DeviceProduct Code: CL3030Lot Numbers: 15045606, 15055430, 15065858, 15075121, 15075411, 15075821 and 15085378ARTG Number: 174371
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd