Recall Z-0106-2015 ยท GZL Electrode, Depth
Ad-Tech Medical Instrument Corporation
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 Appl
| Date | Oct 21, 2014 (initiated Oct 8, 2014) |
| Status | Terminated |
| 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. . |
| 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, customersupport@adtechmedical.com. For additional information they can use the same number. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944061 | CUEVA CRANIAL NERVE ELECTRODE Ad-Tech Medical Instrument Corp, Jan 20, 1995 |