Events

Rappel de Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Verathon Medical 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-2015-RN-00461-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-03
  • 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-2015-RN-00461-1
  • 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
    Verathon, manufacturer of glidescope video laryngoscopes, is revising the operations and maintenance manuals (omm) for certain glidescope gvl and avl reusable laryngoscope blades. the new omms specifically state compatibility limitations of the reusable video laryngoscope validated through simulated use cycles, using certain cleaning and disinfection agents. also, for the purpose of cleaning/disinfecting reusable blades, the following chemicals have been removed from the omms:• bleach (sodium hypochlorite)• isopropyl alcohol solution• liquid hydrogen peroxide (7.5%)there is no change to the safety information provided in the omm regarding inspection of the laryngoscope blade before and after every use to ensure patient safety.
  • Action
    Verathon is informing users regarding updates to the following Operations and Maintenance Manuals: • GVL Operations and Maintenance Manual: 0900-1204-08-60 • AVL Operations and Maintenance Manual: 0900-4200-02-60 The updated Operations and Maintenance Manuals can be found at www.verathon.com. This action has been closed-out on 11/08/2016.

Device

Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3
  • Modèle / numéro de série
    Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3Part Number( PN): 0574-0007Serial Number Range(SN) : MD131860 - MD151622GVL 4PN: 0574-0001SN: LG131995 - LG151773GVL 5PN: 0574-0030SN: XL131578 - XL151524AVL 20574-0118AC131852 - AC151510AVL 30574-0115AD131589 - AD151506AVL 40574-0116AE131587 - AE151558AVL 50574-0117AF131504 - AF151500ARTG Number: 235136
  • Manufacturer
    Verathon Medical Australia Pty Ltd

Manufacturer

Verathon Medical Australia Pty Ltd