J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
Reported: March 28, 2018 Initiated: February 8, 2018 #Z-1155-2018
Product Description
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
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.
Details
- Recalling Firm
- Bovie Medical Corporation
- Units Affected
- 5416 units
- Distribution
- worldwide
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B. Recalled by Bovie Medical Corporation. Units affected: 5416 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 28, 2018. Severity: Moderate. Recall number: Z-1155-2018.
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