FDAFDA · Food and drugs·Recall number Z-1156-2018
J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Published March 28, 2018 · Recall initiated: February 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bovie Medical Corporation
- Distributor
- worldwide
- Lot
- All lots manufactured since 01/01/2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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