Z-2648-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- July 18, 2016
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95
Product Description
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 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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
Code Information
Lot 0316D.