Events

Rappel de Coban 2 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-00208-1
  • Classe de risque de l'événement
    Class II
  • 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-00208-1
  • 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 advised that during printing an operator error occurred where the foil used as the primary packaging for coban 2 shows "coban 2 lite" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (purple for coban 2) are correct. if coban 2 is used (rather than coban 2 lite) for a patient requiring moderate compression, a reduced blood circulation in the extremity is a possible consequence. this could lead to local necrosis or complete ischemia of the lower leg.
  • Action
    3M Australia is advising users to inspect stock and quarantine the affected batch prior to returning to 3M.

Device

Coban 2 Compression Layer (active support bandage)
  • Modèle / numéro de série
    Coban 2 Compression Layer (active support bandage)Product Code: 20024ID Number: DH888822474Lot Number: 2018-12AQExpiry Date: Dec 2018ARTG Number: 235181
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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