Reported Oct 29, 2014 · Terminated
Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches.…
Ad-Tech Medical Instrument Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ad-Tech Medical Instrument Corporation · 1901 William St · Racine, WI · 53404-1876
Is this the product you have?
- Box Label3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX
- Pouch labelsEach kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX
- Box Label2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX
- Pouch labelsEach kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX
- Lot codes and dates
Lot number 208140447 Batch Number 0060002Lot Number 208140458 Batch Number 0061723LotNumber208140487R Batch Number 0067938
- Amount recalled
- 13 kits (26 electrodes, 26 applicator wands, 26 leadwires).
Where it was sold
Why it was recalled
The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ad-Tech Medical Instrument Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.