Bovie Medical recalls J-Plasma Precise 360(R) devices with specific catalog numbers and production dates due to risk of patient fluid backflow and cross-contamination if the 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 J-Plasma Precise 360(R) surgical devices with catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, and BVX-450NR. The recall is because the cable plug might not seal properly, which could let patient fluids flow back into the device and cause cross-contamination if the generator is reused.
The handpiece cable plug may not insert fully into the generator receptacle, creating an incomplete helium seal. This can allow patient fluids to backflow into the handpiece and generator receptacle, increasing the risk of cross-contamination if the generator is reused.
Surgical device users who own or use the J-Plasma Precise 360(R) devices with the listed catalog numbers. Healthcare professionals and patients undergoing procedures using these devices are at risk of cross-contamination.
Check for the catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, or BVX-450NR on the device. These models were manufactured starting January 1, 2014.
Identify the catalog number on the device to confirm if it is in the recalled list.
Reach out to Bovie Medical for guidance on next steps if the device is recalled.
Bovie Medical is recalling J-Plasma Precise 360(R) devices with catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, and BVX-450NR due to a risk of patient fluid backflow and cross-contamination if the generator is reused.
Check for the catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, or BVX-450NR on the device. These models were manufactured starting January 1, 2014.
Contact Bovie Medical for guidance on next steps if the device is recalled.
We’ve drafted a message you can send Bovie Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1156-2018 — Bovie Medical Bovie Medical Hello, I own a Bovie Medical that is covered by recall Z-1156-2018 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.
