Z-1154-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- February 8, 2018
- Termination Date
- September 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6906 units
Product Description
J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
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.
Distribution Pattern
worldwide
Code Information
All lots manufactured since 01/01/2014