2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical stimulator/locator for recur

FDA device recall Z-0798-2010 · posted 2010-02-22 · Terminated

Recall details

Recalling firm

Neurovision Medical Products Inc

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

ETN

Quantity affected

4143

Distribution

Nationwide: CA CO FL GA IL LA MI ND NY OH PA TX UT WA WI)

Date initiated

2010-01-11

Date posted

2010-02-22

Date terminated

2011-04-21

Location

Ventura, CA

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