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U.S. Department of Health and Human Services

Class 2 Device Recall HNM Disposable Bipolar Ablators

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 Class 2 Device Recall HNM Disposable Bipolar Ablatorssee related information
Date Initiated by FirmFebruary 01, 2021
Create DateFebruary 26, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1154-2021
Recall Event ID 87274
510(K)NumberK161558 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductHNM 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 HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).
Recalling Firm/
Manufacturer		 Bovie Medical Corporation
5115 Ulmerton Rd
Clearwater FL 33760-4004
For Additional Information ContactTopaz 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
ActionThe firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.
Quantity in Commerce3862 units
DistributionUS Nationwide distribution in the states of CA and FL.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEI
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