PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 31, 2016 Initiated: July 18, 2016 #Z-2646-2016

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Bovie Medical Corporation
Units Affected
95
Distribution
Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
Location
Clearwater, FL

Frequently Asked Questions

What product 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.. Recalled by Bovie Medical Corporation. Units affected: 95.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2646-2016.