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U.S. Department of Health and Human Services

Class 2 Device Recall PadPro(R) Adult Radiotransparent Multifunction Electrodes

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  Class 2 Device Recall PadPro(R) Adult Radiotransparent Multifunction Electrodes see related information
Date Initiated by Firm May 03, 2013
Date Posted May 13, 2013
Recall Status1 Terminated 3 on August 25, 2015
Recall Number Z-1317-2013
Recall Event ID 65112
510(K)Number K014209  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C.

The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
Code Information Lot Code Y092012-21, Manufacture Date 10/10/2012;  Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013;  Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013
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		 ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.
FDA Determined
Cause 2		 Component design/selection
Action ConMed sent a URGENT: Field Safety Notice letter dated May 3, 2013, 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 please review your inventory for any of the devices listed on Attachment I. Business Reply Forms were sent to the domestic and foreign consignees on May 3, 2013. The domestic notices were mailed by USP Priority Mail pouches. The recall is being conducted to the end user level. We ask that you contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please call 1 315-624-3237 or fax to +1 315-624-3225.
Quantity in Commerce Domestic: 49,010; Foreign: 600
Distribution Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.
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 = MKJ and Original Applicant = PADPRO LLC.
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