Verathon Issues Voluntary Recall of Certain GlideScope GVL Video Laryngoscope Reusable Blades - News - @ JEMS.com


Verathon Issues Voluntary Recall of Certain GlideScope GVL Video Laryngoscope Reusable Blades

Blades prone to developing cracks and/or breaking across the tip of the blade

 

 
 
 

PRNewswire | | Monday, December 3, 2012


BOTHELL, Wash., Nov. 29, 2012 // -- Verathon Inc., Bothell, Washington, is initiating a voluntary recall of GlideScope GVL Video Laryngoscopes reusable blades that were manufactured between December 2010 and August 2011. These laryngoscope blades have been found to be prone to developing cracks and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in patient's mouths and obstructing the airway or being swallowed.

Healthcare facilities that have GlideScope GVL reusable blades that are being recalled should stop using the blades and contact Verathon Customer Care to obtain a replacement blade, if one has not already been provided.  Customers should also contact Customer Care regarding any other questions about the recall.  Customer Care can be reached at (800) 331-2313 (U.S. and Canada) or (425) 867-1348 (international), Monday through Friday from 6:00am to 5:00pm PST for the United States and 6:00am to 4:30pm PST outside of the United States.  Customers may also email the company at cservice@verathon.com.

The recall includes the following models within the specified serial number ranges:

GlideScope GVL 3, 0574-0007: MD10500 to MD112387

GlideScope GVL 4, 0574-0001: LG105000 to LG112758

GlideScope GVL 5, 0574-0030: XL105000 to XL111798

The firm voluntarily recalled the products after learning about design characteristics leading to cracked and broken blades. FDA has been apprised of this action.

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.  This cracking may eventually cause the blade tip to break and the product to fail.  To date, no patient injuries due to this issue have been reported to Verathon.

GlideScope GVL Video Laryngoscopes are used only by healthcare professionals and were distributed directly to hospitals and other healthcare facilities throughout the United States, Canada, and other foreign countries.  Affected GlideScope GVL reusable blades can be identified by reference to the serial number engraved on the metal label on the handle of the GlideScope GVL blade.

Verathon has notified its distributors and customers by mail and by telephone or in-person visits and is arranging for return and replacement of all recalled products.

Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
 




Connect: Have a thought or feedback about this? Add your comment now
Related Topics: News, Company & People News

 
What's Your Take? Comment Now ...

Buyer's Guide Featured Companies

Featured Careers & Jobs in EMS

Get JEMS in Your Inbox

 

Fire EMS Blogs


Blogger Browser

Today's Featured Posts

 

EMS Airway Clinic

Improving Survival from Cardiac Arrest Using ACD-CPR + ITD

Using active compression-decompression CPR with an ITD has been shown to improve 1-year survival from cardiac arrest by 33%.
More >

Multimedia Thumb

Philadelphia Fire Department Apologizes for Medic’s Jab at Police

Union head calls photos a slap in the face of officers.
Watch It >


Multimedia Thumb

D.C. Fire and EMS Crews Blame New Technology for Patient’s Death

Delayed response blamed on recurring dispatch problems.
Watch It >


Multimedia Thumb

Suspect Steals, Crashes Maryland Ambulance

One killed, others injured in Prince George’s County crash.
Watch It >


Multimedia Thumb

Truck Strikes Pedestrians in Scotland

Six killed in downtown Glasgow.
More >


Multimedia Thumb

Tennessee Trench Rescue

Worker pulled from Roane County worksite.
More >


Multimedia Thumb

Time’s Ebola Firefighters

Doctors, nurses and others saluted for fighting virus.
More >


Multimedia Thumb

Braun Ambulances' EZ Door Forward

Helps to create a safer ambulance module.
Watch It >


Multimedia Thumb

VividTrac offered by Vivid Medical - EMS Today 2013

VividTrac, affordable high performance video intubation device.
Watch It >


Multimedia Thumb

Field Bridge Xpress ePCR on iPad, Android, Kindle Fire

Sneak peek of customizable run forms & more.
Watch It >


More Product Videos >