FDA Issues Class 1 Recall: Verathon GlideScope Video Laryngoscope - Breaking Across the Tip of the Blade
December 17th, 2012
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 could potentially 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: firstname.lastname@example.org.
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. Customers located outside of the US or Canada, please call 1-425-867-1348. Customer Care hours are: Monday through Friday, from 6:00 am to 5:00 pm Pacific Time for the US, and 6:00 am to 4:30 pm Pacific Time outside of the US. Customers may also email the company at: email@example.com.
[12/13/12 Recall Notice - FDA]