Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Electrode , depth

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Electrode , depthsee related information
Date Initiated by FirmOctober 08, 2014
Date PostedOctober 21, 2014
Recall Status1 Terminated 3 on April 08, 2015
Recall NumberZ-0106-2015
Recall Event ID 69436
510(K)NumberK944061 
Product Classification Electrode, Depth - Product Code GZL
ProductBox 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 ContactCustomer 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
ActionConsignees 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 Commerce13 kits (26 electrodes, 26 applicator wands, 26 leadwires).
DistributionWorldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GZL
-
-