Recall Z-2648-2016— Bovie Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Bovie Medical Corporation, initiated 2016-07-18, terminated 2016-12-14. It names one FDA 510(k) clearance: K152570. 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 tissue during open and laparoscopic surgical procedures.. 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..
- Recalling firm
- Bovie Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-18
- Terminated
- 2016-12-14
- Firm location
- Clearwater, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.