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U.S. Department of Health and Human Services

Class 2 Device Recall Velocity Disposable Bipolar Ablators

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  Class 2 Device Recall Velocity Disposable Bipolar Ablators see related information
Date Initiated by Firm February 01, 2021
Create Date February 26, 2021
Recall Status1 Open3, Classified
Recall Number Z-1153-2021
Recall Event ID 87274
510(K)Number K161558  K152777  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Code Information Catalog Numbers 7201 (lots 0217H, 0317J, 0417B, 0417F, 0417H, 0618K, 0718B, 0718D, 0718F, 0419J, 0519J, 0120F, 0420B, 0720K, 0720M, 0820L, 0117D, 0117F, 1020L); 7205 (lots 0217B, 0317L); 7206 (lots 0217B, 0317L); 7201-01 (lots 0920B, 0920D, 0920H); 7203 (0217F, 0317B, 0317L, 0417H).
Recalling Firm/
Manufacturer		 Bovie Medical Corporation
5115 Ulmerton Rd
Clearwater FL 33760-4004
For Additional Information Contact Topaz J. Kirlew
727-803-8671
Manufacturer Reason
for Recall		 There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
FDA Determined
Cause 2		 Device Design
Action The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.
Quantity in Commerce 5894 units
Distribution US Nationwide distribution in the states of CA and FL.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = BOVIE MEDICAL CORPORATION
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