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U.S. Department of Health and Human Services

Class 1 Device Recall The GlideScope Video Laryngoscope (GVL) GVL 3, GVL4, GVL5

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  Class 1 Device Recall The GlideScope Video Laryngoscope (GVL) GVL 3, GVL4, GVL5 see related information
Date Initiated by Firm October 25, 2012
Date Posted December 07, 2012
Recall Status1 Terminated 3 on September 27, 2013
Recall Number Z-0478-2013
Recall Event ID 63635
Product Classification Laryngoscope, rigid - Product Code CCW
Product The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor.

The affected GVL and Part numbers are GVL 3  0574-0007, GVL 4  0574-0001, and GVL 5  0574-0030.

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.
Code Information Serial numbers range for GVL3: 0574-0007/ MD105000 to MD112387; Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758; Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798.
Recalling Firm/
Manufacturer		 Verathon, Inc.
20001 N Creek Pkwy
Bothell WA 98011-8218
For Additional Information Contact
800-331-2313
Manufacturer Reason
for Recall		 Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.
FDA Determined
Cause 2		 Device Design
Action The firm, Verathon, sent an "URGENT - Medical Device Recall" letter dated October 25, 2012, to their consignees/cutomers. The letter described the product, problem, and actions to be taken. The customers were instructed to return the recalled blades back to Verathon and complete and return the Device Recall Notification Reply Form via fax to (425) 883-2896 or email: cservice@verathon.com. All returned products will be quarantined and will be destroyed later. Verathon will replace the affected video laryngoscope blade at no cost to customers. Customers in Canada and US with questions can call 800-331-2313. If you are located outside of the US or Canada, please call 425-867-1348.
Quantity in Commerce total 2710 units
Distribution Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: Argentina, Australia, Canada, China, France, Germany, Indonesia, Japan, The Netherlands, Pakistan, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom, and Venezuela.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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