Events

Rappel de Bard ArcticSun ArticGel Pads

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-00770-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-06-27
  • 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-00770-1
  • 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 confirmed that lot ngar0462 is incorrectly identified as 317-09 (large kit) rather than 317-07 (medium kit) on the product (shelf) box. specifically, the shelf box has a black tick mark in the catalogue marked 317-09 instead of 317-07. the shelf box label with barcode and the pouch label is correctly identified as 317-07 and lot number ngar0462. this mislabelling could potentially result in a slight delay in therapy but is not associated with long term or residual clinical consequences.
  • Action
    Bard Australia is requesting that following an inspection of stock on hand, customers should cross out the incorrectly marked line and tick the correct box “317-07”. The Recall for Product Correction does not require affected stock to be returned. Affected stock can remain on your shelves.

Device

Bard ArcticSun ArticGel Pads
  • Modèle / numéro de série
    Bard ArcticSun ArticGel PadsProduct Code: 317-07Lot Number: NGAR0462 ARTG Number: 262560
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd