| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00133-1 |
| Product Name/Description |
Glidescope Titanium Single-Use Video Laryngoscope Blades
Product: LoPro S3, LoPro S4, MAC S3 & MAC S4
Single Blade and Box of 10
Multiple Model Numbers
Multiple Lot Numbers
ARTG Number: 235136 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
The affected GlideScope (GS) Titanium (Ti) Single Use (SU) video laryngoscope blades may cause significant disruption (flickering) in the video laryngoscopy image during an intubation procedure.
If a GlideScope Titanium SU blade causes image flickering during an intubation procedure, there may be a short delay while the physician completes the intubation with a disrupted video image. If flickering is so severe that the video image cannot be relied upon to complete the intubation, then the failure of the intubation procedure, and accompanying delay while a different SU blade or laryngoscope is located, could result in patient death or serious injury.
At this time, Verathon is not aware of any instances of patient injuries or deaths attributed to this potential failure. |
| Recall Action |
Recall |
| Recall Action Instructions |
Verathon is advising users to inspect stock and quarantine the affected units prior to their return. Verathon will replace the affected units. This action has been closed-out on 09/05/2017. |
| Contact Information |
1800 613 603 - Verathon Medical Australia |