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.
FDA Recall Z-1852-2017 · Posted 2017-04-18
Recalling FirmVerathon Inc
Recall StatusTerminated
Product CodeCCW
Date Initiated2017-03-03
Date Terminated2017-08-28
Product QuantityTotal 292 boxes (US= 254 boxes; International = 38 boxes)
Reason for Recall
Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Firm 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 [email protected] 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 [email protected].
Root Cause
Process design
Distribution Pattern
Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.