Device 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.
Z-1852-2017
Product summary
- Firm
- Verathon Inc
- Event
- Event 76642
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 292 boxes (US= 254 boxes; International = 38 boxes)
- Official record key
device-enforcement:Z-1852-2017
Official wording
Reason: Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Code information: Lot GC32825
Distribution pattern: Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.
Derived failure modes
-
Unknown
Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).