Device 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.
Z-0106-2015
Product summary
- Event
- Event 69436
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 kits (26 electrodes, 26 applicator wands, 26 leadwires).
- Official record key
device-enforcement:Z-0106-2015
Official wording
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. .
Code information: Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.
Distribution pattern: Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.
Derived failure modes
-
Unknown
The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .