Recall Z-1558-2013— Verathon, Inc.

Class I FDA medical device recall by Verathon, Inc., initiated 2013-05-08, terminated 2013-12-17. FDA's recall record names no specific 510(k) clearance for this event. Product: GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: 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. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life supporting. The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.. Reason: Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation..

Recalling firm

Verathon, Inc.

Classification

Class I

Status

Terminated

Initiated

2013-05-08

Terminated

2013-12-17

Firm location

Bothell, WA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.