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.
Reported: October 31, 2018 Initiated: June 18, 2018 #Z-0198-2019
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Bovie Medical Corporation
- Units Affected
- 1,176 total units
- Distribution
- Worldwide Distribution: US (nationwide) to states of:: CA, CO, FL, ID, IL, MD, MO, NJ, NY, OH, OR, PA,, TX.; and countries of: Austria, Bahrain, Belgium, Bulgaria, Cyprus, Finland, Great Britain, Hungary, Ireland, Israel, Italy, Qatar, Scandinavia, Slovakia, Switzerland, Turkey, and United Arab Emirates.
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bovie Medical Corporation. Units affected: 1,176 total units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0198-2019.
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