| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00461-1 |
| Product Name/Description |
Verathon GlideScope GVL and AVL Reusable Video Laryngoscope Blades
GVL 3
Part Number( PN): 0574-0007
Serial Number Range(SN) : MD131860 - MD151622
GVL 4
PN: 0574-0001
SN: LG131995 - LG151773
GVL 5
PN: 0574-0030
SN: XL131578 - XL151524
AVL 2
0574-0118
AC131852 - AC151510
AVL 3
0574-0115
AD131589 - AD151506
AVL 4
0574-0116
AE131587 - AE151558
AVL 5
0574-0117
AF131504 - AF151500
ARTG Number: 235136 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1800 613 603 Verathon Medical |