FDAClass IIAugust 31, 2016

BVX-450BR Bovie Precise 360 Handpiece 45cm recall

BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft…

Why was BVX-450BR Bovie Precise 360 Handpiece 45cm 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 0316D.

Product
BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft…
Recalling firm
Bovie Medical Corporation
Quantity
95
Distribution
Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
Recall date
August 31, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls