Recall Z-1153-2018— Bovie Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Bovie Medical Corporation, initiated 2018-02-08, terminated 2020-09-17. It names one FDA 510(k) clearance: K170188. Product: J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS. Reason: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused..
- Recalling firm
- Bovie Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-08
- Terminated
- 2020-09-17
- 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
J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
Reason for recall
Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
Data sourced from openFDA. This site is unofficial and independent of the FDA.