Bovie Medical Recalls J-Plasma Precise OPEN Devices Due to Seal Defect
Bovie Medical is recalling 1,005 J-Plasma Precise OPEN units worldwide because a cable plug defect may cause an incomplete helium seal, risking cross-contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (cross-contamination) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Bovie Medical Corporation is issuing a correction for 1,005 units of the J-Plasma Precise(R) OPEN medical device. The affected catalog numbers are BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, and BVX-150-BPS. These devices were distributed worldwide, and the recall covers all lots manufactured since January 1, 2014.
The recall addresses a defect where the handpiece cable plug may not insert completely into the generator receptacle. This incomplete insertion can result in an incomplete helium seal. If the seal is not complete, there is a potential for patient fluid to backflow into the handpiece and the generator receptacle.
This backflow creates a risk of cross-contamination if the generator is reused. The source text does not report any specific illnesses or injuries associated with this defect. Users should contact Bovie Medical Corporation for instructions on how to address this correction.
The recalled product
- Product
- J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
- Manufacturer
- Bovie Medical Corporation
- Affected units
- 1,005
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots manufactured since 01/01/2014
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Bovie Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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