Recall Z-0421-2016— Verathon, Inc.
Class II · Terminated
Class II FDA medical device recall by Verathon, Inc., initiated 2015-11-30, terminated 2016-08-22. FDA's recall record names no specific 510(k) clearance for this event. Product: GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.. Reason: Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation..
- Recalling firm
- Verathon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-30
- Terminated
- 2016-08-22
- Firm location
- Bothell, WA, United States
Product description
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.
Reason for recall
Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.