Bovie Medical Corporation recalls BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, co…

Recall date

July 18, 2016

Source

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

Recall number

Z-2646-2016

FDA classification

Class II

Brand / firm

Bovie Medical Corporation

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.

Why it was recalled

The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

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

What was recalled

BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.