Z-1157-2018 Class II Terminated
FDA device recall Z-1157-2018 was initiated by Bovie Medical Corporation on Feb 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 Sep 17, 2020). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 28, 2018
- Initiation Date
- Feb 8, 2018
- Termination Date
- Sep 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1157-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026