Recall Z-0420-2016— Verathon, Inc.

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 Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. GVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor.. 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

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