Events

Rappel de 3M Bair Hugger Full Access Underbody Blanket

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-00102-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-06
  • 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-00102-1
  • 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
    3m recently became aware that a design change to the bair hugger full access underbody blanket, models 63500, can make them more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. the health risk associated with this issue is if blankets are only partially inflated during use in surgery, it could result in incomplete warming therapy. loss of therapy may lead to in advert perioperative hypothermia. this recall does not affect any other lots of 3m bair hugger full access underbody blanket.
  • Action
    3M is advising users to inspect inventory and quarantine affected stock of the specified lot numbers immediately to prevent further use. 3M will be in contact with users to arrange collection of affected stock.

Device

3M Bair Hugger Full Access Underbody Blanket
  • Modèle / numéro de série
    3M Bair Hugger Full Access Underbody BlanketModels 63500Manufactured between: 2nd October 2017 - 20th November 2017Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366Product Code: 70200791203ARTG Number: 218944
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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