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U.S. Department of Health and Human Services

Class 2 Device Recall R2 Adult Zoll NonRadiolucent Multifunction Electrodes

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  Class 2 Device Recall R2 Adult Zoll NonRadiolucent Multifunction Electrodes see related information
Date Initiated by Firm March 09, 2011
Date Posted January 12, 2012
Recall Status1 Terminated 3 on January 12, 2012
Recall Number Z-0735-2012
Recall Event ID 60700
510(K)Number K964469  
Product Classification Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
Product R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505.

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 1006284
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Road
Utica NY 13502
For Additional Information Contact M. Patricia Cotter
315-624-3533
Manufacturer Reason
for Recall		 The product lot was assembled with an R2 Connector, rather than a Zoll Connector.
FDA Determined
Cause 2		 Packaging process control
Action ConMed Corporation sent an "URGENT: DEVICE RECALL" letter dated March 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to stop use of the devices immediately. A Business Reply Form was attached for customers to complete and return to the firm via fax to 315-624-3225. Additionally, instructions were provided on how to return the affected devices. Contact the ConMed Recall Coordinator at 315-624-3237 for questions regarding this notice.
Quantity in Commerce 190 sets (2 pads per set in individual pouch)
Distribution Nationwide Distribution-including the states of AZ, CA, IN, and MI.
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 = LDD and Original Applicant = CARDIOTRONICS SYSTEMS, INC.
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