Z-0106-2015Class II

Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains...

Name: Z-0106-2015 Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains...
Creator: Ad-Tech Medical Instrument Corporation
Published: 2014-10-08
License: https://open.fda.gov/license/

AD-Tech Medical Instrument Corp. / initiated 2014-10-08 / Terminated / root cause: manufacturing process

FDA source

Ad-Tech Medical Instrument Corporation began a recall of 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... on 2014-10-08. FDA classified it as Class II and gives the reason as "The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0106-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-08
Posted: 2014-10-21
Terminated: 2015-04-08
Recalling firm: AD-Tech Medical Instrument Corp.
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.
Product code: GZL Electrode, Depth
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. .
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent on 10/8/2014 an AD-TECH "Medical Device Recall" letter dated October 6, 2014. The letter described the Reason for the Voluntary Recall, Risk to Health, Action to be taken by the Customer, Product and Distribution Information and Other Information. Requested consignees to return the "Acknowledgement and Receipt Form" to their Ad-Tech Clinical Specialists Fax 262-634-5668, Telephone 262-634-1555, [email protected]. For additional information they can use the same number.
Quantity in commerce: 13 kits (26 electrodes, 26 applicator wands, 26 leadwires).
Distribution: Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.
Product codes and lots: Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0106-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0106-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-21

Product code GZL

K944061Class IICueva Cranial Nerve ElectrodeAd-Tech Medical Instrument Corp / cleared 1995-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)