Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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. CNE

U.S. FDA — Device Enforcement · United States · 2014-10-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0106-2015
Date of alert: 2014-10-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ad-Tech Medical Instrument Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 208140447

Reported risk: The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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