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GlideScope Titanium Single-Use Video Laryngoscope by Verathon: Class I Recall - Potential Video Feed Disruption
AUDIENCE: Risk Manager, Otolaryngology, Anesthesiology
ISSUE: Verathon Incorporated is recalling the GlideScope Titanium Single-Use Video Laryngoscope because of a potential disruption in the video feed from the camera in the laryngoscope blades to the monitor. A disrupted or unstable video image may lead to delayed tracheal tube insertion, intubation failure and other serious adverse health consequences, including low levels of oxygen in the blood (hypoxemia), end organ damage or death.
See the Recall Notice for a listing of affected model codes and lot numbers.
BACKGROUND: The GlideScope Titanium Single-Use Video Laryngoscope is used to obtain a clear view of the vocal cords and to assist in the insertion of a tracheal tube used during other medical procedures (i.e. general anesthesia).
RECOMMENDATION: On January 29, 2016, Verathon Inc. sent a Customer Recall letter instructing customers to:
- Review the list of affected products and lots
- Fill out and return the attached Recall Response Form even if the inventory was free of affected products
- Return affected products along with the Recall Response Form, or to destroy them and provide evidence of destruction
- Contact the firm’s customer care line at 1-800-331-2313 to arrange for delivery of replacement products
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the 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
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