Z-0106-2015 Class II Terminated
FDA device recall Z-0106-2015 was initiated by Ad-Tech Medical Instrument Corporation on October 8, 2014 and is designated Class II. 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. . The recall status is terminated (terminated April 8, 2015). Affected quantity: 13 kits (26 electrodes, 26 applicator wands, 26 leadwires)..
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2014
- Initiation Date
- October 8, 2014
- Termination Date
- April 8, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 kits (26 electrodes, 26 applicator wands, 26 leadwires).
Product Description
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.
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. .
Distribution Pattern
Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.
Code Information
Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.