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Verathon GlideScope Video Laryngoscope Reusable Blades: Class 1 Recall - Breaking Across the Tip of the Blade
AUDIENCE: Anesthesiologists, Risk Managers
ISSUE: The GlideScope GVL Video Laryngoscope Resuable Blades are being recalled due to potential cracking and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in a patient’s mouth and obstructing the airway or being swallowed, which may cause serious adverse health consequences, including death.
The affected GlideScope GVL blades are at risk of developing stress cracks at the blade tip that may not be readily visible during routine inspection prior to intubation.
BACKGROUND: 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. This product was manufactured from December 1, 2010 through August, 31, 2011 and distributed from December 14, 2010 through March 6, 2012.
RECOMMENDATION: Stop using the blades. Contact Verathon Customer Care to obtain replacement blades. Return the recalled blades back to Verathon.
Complete and return the Device Recall Notification Reply Form by fax to 1-425-883-2896 or by email at: cservice@xxxxxxxxxxxx.
All returned products will be quarantined and destroyed later. Verathon will replace the affected video laryngoscope blades at no cost to customers. Customers in the U.S. and Canada with questions can call 1-800-331-2313. For customers located outside of the U.S. or Canada, please call 1-425-867-1348. Customer Care hours are: Monday through Friday, from 6:00am to 5:00pm Pacific Time for the U.S., and 6:00am to 4:30pm Pacific Time outside of the U.S. Customers may also email the company at cservice@xxxxxxxxxxxx.
Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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