Home / Recalls / Medical Devices
Bovie Medical Corporation recalls J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Recalled March 28, 2018 · FDA recall Z-1156-2018 · Bovie Medical
Hazard
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. · FDA Class II
Units
595 units
Sold at
worldwide
Description
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.
Product
J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Manufacturer(s)
Bovie Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →