Class 2 Device Recall JPlasma Precise(R) FLEX

• Date Initiated by Firm: February 08, 2018
• Create Date: March 21, 2018
• Recall Status: Terminated on September 17, 2020
• Recall Number: Z-1157-2018
• Recall Event ID: 79398
• 510(K)Number: K170188
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
• Code Information: All lots manufactured since 01/01/2014
• Recalling Firm/ Manufacturer: Bovie Medical Corporation; 5115 Ulmerton Rd; Clearwater FL 33760-4004
• For Additional Information Contact: Dr. Topaz J. Kirlew, MBA, MT(ASCP); 727-803-8617
• Manufacturer 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.
• FDA Determined 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 After receiving these labels, please follow the attached instructions on how to add each of the insert stuffer notice and the outer box label to each of the boxes that you have on your possession. o Document the number of labels/stuffers added to each of the products on the Inventory List provided, sign and date to confirm this was performed. o Return the signed document to me via email at Rubiela.maldonado@boviemed.com. 2. Inform your customers about the correction: o Identify and contact your customers that have received the product affected by this correction. o Provide them with a copy of the Urgent Medical Device Correction Template attached to this letter. o Track and document the customer responses to ensure 100% effectiveness. o Provide us a summary of the effectiveness of this correction (number of customers impacted and number of responses received)." The remaining consignees (users of the device) were instructed as follows: "ACTIONS: At the end of each procedure, inspect the handpiece cable plug and generator receptacle for the presence of fluids. If fluids are present, immediately discontinue use of the generator. In addition to following the J-Plasma handpiece Instructions for Use, immediately begin to follow the supplemental instructions provided below to ensure that the J-Plasma handpiece cable plug is properly and co
• Quantity in Commerce: 12 units
• Distribution: worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEI