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U.S. Department of Health and Human Services

Class 2 Device Recall Dragonfly 2Channel Laryngeal Surface Electrode

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  Class 2 Device Recall Dragonfly 2Channel Laryngeal Surface Electrode see related information
Date Initiated by Firm January 11, 2010
Date Posted February 22, 2010
Recall Status1 Terminated 3 on April 21, 2011
Recall Number Z-0798-2010
Recall Event ID 54233
510(K)Number K003745  
Product Classification stimulator, nerve - Product Code ETN
Product 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL)
For use as a Surgical stimulator/locator for recurrent laryngeal nerve.
Code Information Lot numbers 113008, 054409, 096709
Recalling Firm/
Manufacturer		 Neurovision Medical Products Inc
275 Burnett Ave
Ventura CA 93003
For Additional Information Contact
805-212-8306
Manufacturer Reason
for Recall		 This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the adhesive from one pad to the other creating an electrical short. Use of one of these defective electrodes could lead to a failure to monitor. Our investigation has c
FDA Determined
Cause 2		 Other
Action URGENT RECALL: Medical Device Letter dated 1/7/10. The letter identified the affected product and provided a list of necessary actions for customers to take. The customers should immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify their customers and notify them at once of this product recall. Their notification to their customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any failure to monitor. Please complete and return the enclosed response form as soon as possible. If you have any questions, call Ryan Rea or Kevin Rea, at 866-815-6999.
Quantity in Commerce 4143
Distribution Nationwide: CA CO FL GA IL LA MI ND NY OH PA TX UT WA WI)
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 = ETN and Original Applicant = RLN SYSTEMS, INC.
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