FDAJune 18, 2018device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
bovie medicalbovie
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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