medical Class II Updated 2018-10-31

Bovie Medical Corporation recalls J-Plasma Precise 360, single use, disposable. The Bovie

Recalled Product

J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

Hazard / Issue

There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR. All lot number are included that have been manufactured since 05/01/2016.
View official government recall

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