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U.S. Department of Health and Human Services

Class 2 Device Recall GlideScope GVL 2 Stat

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  Class 2 Device Recall GlideScope GVL 2 Stat see related information
Date Initiated by Firm March 03, 2017
Date Posted April 18, 2017
Recall Status1 Terminated 3 on August 28, 2017
Recall Number Z-1852-2017
Recall Event ID 76642
Product Classification Laryngoscope, rigid - Product Code CCW
Product It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg).

Part Number 0270-0429: GVL 2 Stat (box of 10 Stats).
Part Number 0574-0027: GVL 2 Stat (single pouched Stat).
Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.
Code Information Lot GC32825
Recalling Firm/
Manufacturer		 Verathon Inc
20001 N Creek Pkwy
Bothell WA 98011-8218
For Additional Information Contact Verathon Customer Care
800-331-2313
Manufacturer Reason
for Recall		 Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
FDA Determined
Cause 2		 Process design
Action Verathon provided a notification letter to their Canadian distributor on March 03, 2017, and distribution of the letter to the rest-of-the-world (ROW) foreign consignees was initiated on March 10, 2017. Verathon intends to send the Urgent Medical Device Recall Glidescope GVL2 Stat letter and Customer Response Form to US consignees by March 31, 2017. Consignees should quarantine and discard any affected product on site, and fill out the attached Recall Response Form and return it to Verathon by fax to (425) 883- 2896, or email to CSNotifications@verathon.com even if they do not have any Stats (blades) subject to the recall. Consignees who have any questions about this voluntary recall, please contact Verathon representative or Verathon Customer Care at (800) 331-2313 (U.S. and Canada). If consignees located outside of the U.S. or Canada, please call (425) 867-1348. Consignees can also send email to cservice@verathon.com.
Quantity in Commerce Total 292 boxes (US= 254 boxes; International = 38 boxes)
Distribution Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.
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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