FDA-Device2018-03-28Class II
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
Bovie Medical Corporation
Hazard
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.
Sold states
worldwide
Affected count
12 units
Manufactured in
5115 Ulmerton Rd, N/A, Clearwater, FL, United States
Products
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1157-2018Don't want to check this manually?
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