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U.S. Department of Health and Human Services

Class 2 Device Recall Electrode , depth

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  Class 2 Device Recall Electrode , depth see related information
Date Initiated by Firm October 08, 2014
Date Posted October 21, 2014
Recall Status1 Terminated 3 on April 08, 2015
Recall Number Z-0106-2015
Recall Event ID 69436
510(K)Number K944061  
Product Classification Electrode, Depth - Product Code GZL
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.
Code Information Lot number 208140447 Batch Number 0060002;  Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.
Recalling Firm/
Manufacturer		 Ad-Tech Medical Instrument Corporation
1901 William St
Racine WI 53404-1876
For Additional Information Contact Customer Support
262-634-1555
Manufacturer 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. .
FDA Determined
Cause 2		 Process control
Action Consignees were sent on 10/8/2014 an AD-TECH "Medical Device Recall" letter dated October 6, 2014. The letter described the Reason for the Voluntary Recall, Risk to Health, Action to be taken by the Customer, Product and Distribution Information and Other Information. Requested consignees to return the "Acknowledgement and Receipt Form" to their Ad-Tech Clinical Specialists Fax 262-634-5668, Telephone 262-634-1555, customersupport@adtechmedical.com. For additional information they can use the same number.
Quantity in Commerce 13 kits (26 electrodes, 26 applicator wands, 26 leadwires).
Distribution Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GZL and Original Applicant = AD-TECH MEDICAL INSTRUMENT CORP.
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