Recall Z-0198-2019— Bovie Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Bovie Medical Corporation, initiated 2018-06-18, terminated 2019-04-08. It names one FDA 510(k) clearance: K152570. Product: J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.. Reason: There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue..
- Recalling firm
- Bovie Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-18
- Terminated
- 2019-04-08
- 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 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.
Reason for recall
There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.