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U.S. Department of Health and Human Services

Class 2 Device Recall R2 Adult R2 NonRadiolucent Multifunction Electrodes

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  Class 2 Device Recall R2 Adult R2 NonRadiolucent Multifunction Electrodes see related information
Date Initiated by Firm March 31, 2011
Date Posted January 25, 2012
Recall Status1 Terminated 3 on January 26, 2012
Recall Number Z-0856-2012
Recall Event ID 60701
510(K)Number K964469  
Product Classification Electrode, electrodcardiograph, multi-function - Product Code MLN
Product R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507

This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.
Code Information Lot 1010194
Recalling Firm/
ConMed Corporation
525 French Road
Utica NY 13502
For Additional Information Contact M. Patricia Cotter
Manufacturer Reason
for Recall
The specific lot was assembled without the rivet cover.
FDA Determined
Cause 2
Employee error
Action ConMed Corporation sent a Urgent Medical Device Recall Letter dated March 25, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately stop use of the device and return it to ConMed Corporation. Please review your inventory for any of the devices listed on Attachment I. If you do not have any devices to return, please follow the instructions in the letter and complete Attachment II, indicating you have no devices and fax it to 315-624-3225. Please complete the attached Business reply form. We apologize for any inconvenience this will cause you or your staff. For further questions please call (315) 797-8375.
Quantity in Commerce 850 sets (2 pads per set in individual pouch)
Distribution Worldwide Distribution -- USA (nationwide) and the countries of Canada, Belgium, Germany and Hong Kong.
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 = MLN and Original Applicant = CARDIOTRONICS SYSTEMS, INC.