Drug recall
J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the…
FDA recall event 80544 · Class II · Bovie Medical Corporation
Key facts
| Event ID | 80544 |
|---|---|
| Recall numbers | Z-0198-2019 |
| Recalling firm | Bovie Medical Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jun 18, 2018 |
| Report date | Oct 31, 2018 |
| Termination date | Apr 8, 2019 |
| City | Clearwater |
| State | FL |
| Country | United States |
| FEI number | 3007593903 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: