Events

Rappel de Supergloves Vinyl Examination Gloves, powdered & powder free

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Supergloves 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-01481-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-16
  • 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-01481-1
  • 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
    Testing by the tga has found that supergloves vinyl examination gloves are not suitable for medical/biological applications because they do not provide an effective barrier suitable for medical or biological protection.
  • Action
    Supergloves Australia Pty Ltd is advising all customers & distributors to quarantine all Supergloves Vinyl Examination Gloves with ARTG # 196064 printed on the box and to contact Supergloves who will arrange for the stocks to be recovered and a credit note issued. This action has been closed-out on 23/05/2017.

Device

Supergloves Vinyl Examination Gloves, powdered & powder free
  • Modèle / numéro de série
    Supergloves Vinyl Examination Gloves, powdered & powder freeAll batchesARTG Number: 196064
  • Manufacturer
    Supergloves Australia Pty Ltd

Manufacturer

Supergloves Australia Pty Ltd
  • Source
    DHTGA