Events

Rappel de Covidien Devon Light Glove (included in multiple Procedure Packs)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medline International Two 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-00064-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-13
  • 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-00064-1
  • 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
    Customers have reported that on rare occasions, the devon light glove may split upon application to the devon light handle adapter. some of the reported splits resulted from difficult application of the light glove to the handle adapter. more recently, clinicians have reported finding splits in the light glove following surgery completion, where no difficulty in application of the light glove was encountered or finding splits directly out of the package. a split in the light glove causes a breach in the sterile field and can increase the potential for infection. there have been two reports in which splits were found at the conclusion of surgery.
  • Action
    Medline is advising users to remove and discard the Covidien Light Glove from the procedure pack at the time of surgery preparation.

Device

Covidien Devon Light Glove (included in multiple Procedure Packs)
  • Modèle / numéro de série
    Covidien Devon Light Glove (included in multiple Procedure Packs)Multiple Product Codes ARTG Number for the Light Glove itself: 186761ARTG Numbers for the affected Procedure Packs containing the Light Glove: 140059, 136870, 137395, 140054 and 140058
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd