Recall Z-0798-2010 ยท ETN Stimulator, Nerve
Neurovision Medical Products Inc
2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical stimulator/locator for recurrent laryngeal nerve.
| Date | Feb 22, 2010 (initiated Jan 11, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 nec |
| Quantity | 4143 |
| Distribution | Nationwide: CA CO FL GA IL LA MI ND NY OH PA TX UT WA WI) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003745 | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET Rln Systems, Inc., Jan 16, 2001 |