Bovie J-Plasma Precise FLEX Recall for Incomplete Cable Seal
Bovie Medical is recalling 12 units of the J-Plasma Precise FLEX due to a potential seal failure that could allow patient fluid backflow and cross-contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, fitting the High severity criteria.
Plain-English summary
Bovie Medical Corporation is issuing a correction for the J-Plasma Precise(R) FLEX, Catalog Number BVX-500BF. The recall affects 12 units distributed worldwide, including all lots manufactured since January 1, 2014.
The issue involves the incomplete insertion of the handpiece cable plug into the generator receptacle, which results in an incomplete helium seal. This defect creates a potential for patient fluid to backflow into the handpiece and the generator receptacle.
If the generator is reused after such an event, there is a risk of cross-contamination. Users should stop using the affected devices and contact Bovie Medical for further instructions.
The recalled product
- Product
- J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
- Manufacturer
- Bovie Medical Corporation
- Hazard
- Affected units
- 12
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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