Recall Z-0106-2015
Ad-Tech Medical Instrument Corporation · initiated October 8, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.
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. .
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0106-2015
- Initiated
- October 8, 2014
- Posted by FDA
- October 21, 2014
- Terminated
- April 8, 2015
- Product code
- GZL – Electrode, Depth
- 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.
- Recalling firm
- Ad-Tech Medical Instrument Corporation, Racine, WI