PlainRecalls
FDA Devices Moderate 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.

Reported: April 26, 2017 Initiated: March 3, 2017 #Z-1852-2017

Product 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 for Recall

Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).

Details

Recalling Firm
Verathon Inc
Units Affected
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.
Location
Bothell, WA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Verathon Inc. Units affected: Total 292 boxes (US= 254 boxes; International = 38 boxes).
Why was this product recalled?
Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Which agency issued this recall?
This recall was issued by the FDA Devices on April 26, 2017. Severity: Moderate. Recall number: Z-1852-2017.