Events

Rappel de Coban 2 Lite Compression Layer (active support bandage)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par 3M 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-00207-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-02-24
  • 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-00207-1
  • 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 has identified that during printing an operator error occurred where the foil used as the primary packaging for coban 2 lite shows "coban 2" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (green for coban 2 lite) is correct. if coban 2 lite is used by mistake for a patient requiring regular compression, the compression efficacy might not be sufficient. this would be noticed by the health care provider and corrected with the next bandage change.
  • Action
    3M Australia is advising users to inspect stock and quarantine any affected product for return or credit. This action has been closed-out on 30/01/2017.

Device

Coban 2 Lite Compression Layer (active support bandage)
  • Modèle / numéro de série
    Coban 2 Lite Compression Layer (active support bandage)Product Code: 20724ID Number: DH888822441Lot Number: 2017-21APExpiry Date: Dec 2017ARTG Number: 235181
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    DHTGA