FDA recall Z-1156-2018

Product

J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

Reason for recall

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.

Distribution

worldwide

Key facts

Status

Terminated

Initiation date

2018-02-08

Report date

2018-03-28

Termination date

2020-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clearwater, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1156-2018