Events

Recall of Verathon GlideScope GVL and AVL Reusable Video Laryngoscope BladesGVL 3

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Verathon Medical Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00461-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00461-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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