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Class 2 Device Recall HNM Disposable Bipolar Ablators |
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Date Initiated by Firm |
February 01, 2021 |
Create Date |
February 26, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1154-2021 |
Recall Event ID |
87274 |
510(K)Number |
K161558
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Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product |
HNM 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
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For Additional Information Contact |
Topaz J. Kirlew 727-803-8671
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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.
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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 |
3862 units |
Distribution |
US Nationwide distribution in the states of CA and FL. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = BOVIE MEDICAL CORPORATION
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