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FDAFebruary 8, 2018device

J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

bovie medicalbovie

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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