Recall Z-2649-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bovie Medical Corporation
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
| Date | Jul 18, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified by written recall notice sent via certified mail or courier on July 18, 2016 to quarantine their inventory of the Precise 360 Handpiece, identify and contact their customers that have received the affected product and provide the a copy of the attached field safety notice. Customers are requested to return affected product, and return all affected product currently in their possession. All customer inventory should be reviewed, discontinue use, and return all Bovie Precise 360 handpieces to: Quality Assurance Department, Bovie Medical Corporation, 5115 Ulmerton Road, C |
| Quantity | 95 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152570 | Bovie J-Plasma Precise 360 Handpiece Bovie Medical Corporation, Nov 2, 2015 |