Verathon Inc recalls 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…

Recall date

March 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1852-2017

FDA classification

Class II

Brand / firm

Verathon Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.