Bovie Medical recalls J-Plasma Precise OPEN devices with specific catalog numbers and production dates due to risk of patient fluid backflow and cross-contamination if generator is reused.
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.
Bovie Medical is recalling certain J-Plasma Precise OPEN devices because the cable plug might not seat properly in the generator. This could let patient fluids flow back into the device, risking cross-contamination if the generator is reused.
The J-Plasma handpiece cable plug may not fully insert into the generator receptacle, breaking the helium seal. This allows patient fluids to flow back into the handpiece and generator, creating a risk of cross-contamination if the generator is reused.
Healthcare professionals using the J-Plasma Precise OPEN devices with catalog numbers BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, or BVX-150-BPS. Those who reuse the generator without proper sealing are at higher risk of cross-contamination.
Check for catalog numbers BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, or BVX-150-BPS on the device. These models were manufactured starting January 1, 2014.
Ensure the J-Plasma handpiece cable plug is fully inserted into the generator receptacle to maintain the helium seal.
The affected models are J-Plasma Precise OPEN with catalog numbers BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, and BVX-150-BPS.
These devices were manufactured starting January 1, 2014.
The recall addresses the hazard by ensuring proper cable plug insertion to maintain the helium seal, but no specific repair kit or replacement is mentioned in the notice.
We’ve drafted a message you can send Bovie Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1153-2018 — Bovie Medical Bovie Medical Hello, I own a Bovie Medical that is covered by recall Z-1153-2018 from Bovie Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
