Recall Z-0421-2016 ยท CCW Laryngoscope, Rigid
Verathon, Inc.
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.
| Date | Dec 15, 2015 (initiated Nov 30, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | The Urgent Medical Device Recall letter, dated November 30, 2015, had an error on the dates of manufacture for the AVL devices. Once Verathon discovered the incorrect information, the notification letter was revised and it was sent on December 7, 2015 to any customers that received the previous letter between 11/30/15 and 12/2/15. **************************************************************************************** Verathon sent an Urgent Medical Device Recall letter dated November 30, 2015, to all affected consignees. Verathon will, at no cost to you, test your GlideScope GVL and/or |
| Quantity | 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, Malays |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.