Z-1153-2018 Class II Terminated
FDA device recall Z-1153-2018 was initiated by Bovie Medical Corporation on February 8, 2018 and is designated Class II. 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… The recall status is terminated (terminated September 17, 2020). Affected quantity: 1005 units.
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
- 1005 units
Product Description
J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
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