Recall Z-1157-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bovie Medical Corporation
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
| Date | Feb 8, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated their recall on 02/08/2108 by email to distributors, and letter to the remaining consignees. Distributors were directed as follows: "We ask that you immediately: 1. Quarantine your inventory of the J-Plasma Handpieces o Provide us with a list of catalog numbers and quatities that you have on your possession using the attached Inventory List template. o Email the information to me at Rubiela.Maldonado@boviemed.com Note: as soon as we receive the information from you we will ship the box labels and insert stuffer notices for the stock that you have on your possession. o |
| Quantity | 12 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator Bovie Medical Corporation, Mar 8, 2017 |