Events

Rappel de 1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps 1322 3M Comply Lead Free Steam Indicator Tapes

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-2017-RN-00635-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-05-19
  • 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-2017-RN-00635-1
  • 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
    During a recent investigation, the manufacturer confirmed some rolls within the four (4) affected lots failed to meet the visual standard for colour development following exposure to steam sterilisation. if the product fails to meet the colour development standard it could be interpreted that the pack has not been exposed to an adequate sterilisation process.
  • Action
    3M Australia is requesting users to discontinue use of affected products and notify 3M to receive a refund or replacement. Distributors are requested to cease distribution of affected products and forward the recall notification to customers who have received the affected lots. Distributors are further requested to consolidate returned products from their customers with their own affected stock and notify 3M accordingly to receive a refund or replacement.

Device

1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes f...
  • Modèle / numéro de série
    1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps 1322 3M Comply Lead Free Steam Indicator TapesStock Numbers: CT060934651 & CT060934669Roll Sizes: 1322-18MM & 1322-24MM (respectively)1355 3M Comply Lead Free Steam Indicator Tapes for Disposable WrapsStock Numbers: CT060934693 & CT060934701Roll Sizes: 1355-18MM & 1355-24MM (respectively)Lot No: 2018-04RA, 2018-05RB, 2018-06RC & 2018-06RD ARTG Number: 126363
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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