PlainRecalls
FDA Devices Moderate Class II Terminated

GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.

Reported: December 23, 2015 Initiated: November 30, 2015 #Z-0421-2016

Product Description

GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.

Reason for Recall

Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.

Details

Recalling Firm
Verathon, Inc.
Units Affected
448 units (189 units in US and 259 units outside US)
Distribution
Worldwide Distribution - US (nationwide including Puerto Rico) and Internationally to Bahrain, Belgium, Bermuda, Brunei Darussalam, Bulgaria, Canada, China , Czech Republic, Denmark, France, Georgia, Germany, Greece, India , Indonesia, Iran , Israel, Italy , Japan, Kuwait, Lebanon, Malaysia, Morocco, Palestinian Territories, Panama, Peru, Philippines, Republic of Serbia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, and U.A.E.
Location
Bothell, WA

Frequently Asked Questions

What product was recalled? ▼
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.. Recalled by Verathon, Inc.. Units affected: 448 units (189 units in US and 259 units outside US).
Why was this product recalled? ▼
Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2015. Severity: Moderate. Recall number: Z-0421-2016.

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