Events

Rappel de Futuro Quick Strap Ankle Support

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-2018-RN-00116-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-19
  • 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-2018-RN-00116-1
  • 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 is aware that there is natural rubber latex (1%) in the futuro quick strap ankle support. currently packaging of this product does not have an explicit caution statement in relation to latex.The existing caution statement available on this product is "caution: some individuals may be sensitive to neoprene or neoprene blend rubber. if a rash develops, discontinue use and consult a physician".Individuals that are sensitive to latex may develop an allergic reaction.No alleged medical complaints regarding this product have been received in australia during its period of distribution.This recall does not affect any other 3m products.
  • Action
    3M is advising pharmacies to quarantine affected stock and return it to the distributor. 3M will arrange collection of affected devices from distributors.

Device

Futuro Quick Strap Ankle Support
  • Modèle / numéro de série
    Futuro Quick Strap Ankle Support Product Code: 47736EN3M Code: 70005091510All batch/lot numbers are affectedARTG Number: 214679
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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