Reported Mar 28, 2018 · Terminated
J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
Bovie Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bovie Medical Corporation · 5115 Ulmerton Rd · Clearwater, FL · 33760-4004
Is this the product you have?
- J-Plasma Precise(R) OPEN
- Catalog Numbers
BVX-044-BPPBVX-044-BPSBVX-150-BPPBVX-150-BPS
- Lot codes and dates
- All lots manufactured since 01/01/2014
- Amount recalled
- 1005 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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