Bovie Medical Recalls J-Plasma Precise 360 Devices Due to Seal Defect
Bovie Medical is recalling J-Plasma Precise 360 devices because a cable plug defect may allow patient fluid to backflow, creating a risk of 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 the J-Plasma Precise 360(R) devices, specifically catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, and BVX-450NR. The recall affects 595 units that were distributed worldwide. All lots manufactured since January 1, 2014, are included in this recall.
The recall is being issued to address 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.
Healthcare providers and consumers should stop using the affected devices immediately. Users should contact Bovie Medical Corporation for instructions on how to return or replace the devices. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
- Manufacturer
- Bovie Medical Corporation
- Affected units
- 595
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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