FDAFDA · Food and drugs·Recall number Z-0106-2015
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.
Published October 29, 2014 · Recall initiated: October 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Distributor
- Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.
- Lot
- Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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