Verathon, Inc., Certain GlideScope Video Laryngoscope Reusable Blades
Recall Class: Class I
Date Recall Initiated: October 25, 2012
Product: Certain GlideScope Video Laryngoscope (GVL) Reusable Blades
The recall includes the following models within the specified serial number ranges:
- GlideScope GVL3, 0574-0007: MD10500 to MD112387
- GlideScope GVL4: 0574-0001: LG105000 to LG112758
- GlideScope GVL5: 0574-0030: XL105000 to XL111798
The 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.
This product was manufactured from December 1, 2010 through August, 31, 2011 and distributed from December 14, 2010 through March 6, 2012.
Use: 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.
20001 N Creek Pkwy
Bothell, Washington 98011-8218
Reason for Recall: 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.
Public Contact: Customers with questions in the U.S. and Canada can call Verathon at 1-800-331-2313. For customers outside the U.S. or Canada, please call 1-425-867-1348. Customers may also email the company at firstname.lastname@example.org.
FDA District: Seattle District Office
Verathon sent an "URGENT - Medical Device Recall" letter dated October 25, 2012 to their distributors and customers (and by telephone or by in-person visits). The letter described the product, problem, and actions to be taken.
- 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: email@example.com.
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 firstname.lastname@example.org.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.