Bovie Medical Corporation recalls J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS

Recall date

February 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1153-2018

FDA classification

Class II

Brand / firm

Bovie Medical Corporation

Sold / distributed

worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS