Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches.
FDA device recall Z-0106-2015 · posted 2014-10-21 · Terminated
Recall details
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- 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. .
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GZL
- Quantity affected
- 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.
- Date initiated
- 2014-10-08
- Date posted
- 2014-10-21
- Date terminated
- 2015-04-08
- Location
- Racine, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUEVA CRANIAL NERVE ELECTRODE (K944061) | Ad-Tech Medical Instrument Corp | 1995-01-20 |