Z-1852-2017 Class II Terminated

Recalled by Verathon Inc — Bothell, WA

Recall Details

Product Type
Devices
Report Date
April 26, 2017
Initiation Date
March 3, 2017
Termination Date
August 28, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Total 292 boxes (US= 254 boxes; International = 38 boxes)

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)).

Distribution Pattern

Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.

Code Information

Lot GC32825