Drug recall
J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
FDA recall event 79398 · Class II · Bovie Medical Corporation
Key facts
| Event ID | 79398 |
|---|---|
| Recall numbers | Z-1153-2018, Z-1154-2018, Z-1155-2018, Z-1156-2018, Z-1157-2018 |
| Recalling firm | Bovie Medical Corporation |
| Product type | Devices |
| Products | J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR, J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N, J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF, J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS, J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 8, 2018 |
| Report date | Mar 28, 2018 |
| Termination date | Sep 17, 2020 |
| 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: