FDA Enforcement
Class II
Terminated
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.
Recall: Z-1852-2017
·
Reported April 26, 2017
Enforcement
- Recall Number
- Z-1852-2017
- Event ID
- 76642
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Verathon Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 26, 2017
- Initiation Date
- March 3, 2017
- Classification Date
- April 18, 2017
- Termination Date
- August 28, 2017
- Address
- 20001 N Creek Pkwy, N/A, Bothell, WA, 98011-8218, United States
Description
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.
Reason
Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Code Info
Lot GC32825
Distribution
Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.
Quantity
Total 292 boxes (US= 254 boxes; International = 38 boxes)