Recall Z-0106-2015— Ad-Tech Medical Instrument Corporation

Name: FDA recall Z-0106-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-08

Class II · Terminated

Class II FDA medical device recall by Ad-Tech Medical Instrument Corporation, initiated 2014-10-08, terminated 2015-04-08. It names one FDA 510(k) clearance: K944061. Product: Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.. Reason: The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. ..

Recalling firm: Ad-Tech Medical Instrument Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-10-08
Terminated: 2015-04-08
Firm location: Racine, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K944061 — CUEVA CRANIAL NERVE ELECTRODEAd-Tech Medical Instrument Corp·cleared 1995-01-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.

Reason for recall

The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .

Data sourced from openFDA. This site is unofficial and independent of the FDA.