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U.S. Department of Health and Human Services

Class 2 Device Recall PADPRO ADULT Radiotranslucent Pad w/Medtronic connector

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  Class 2 Device Recall PADPRO ADULT Radiotranslucent Pad w/Medtronic connector see related information
Date Initiated by Firm March 08, 2007
Date Posted April 24, 2007
Recall Status1 Terminated 3 on July 16, 2012
Recall Number Z-0757-2007
Recall Event ID 37495
510(K)Number K020203  
Product Classification Defibrillation/Pacing/Cardioversion/Monitoring Electrodes - Product Code MLN
Product PADPRO ADULT Radiotranslucent Pad w/Medtronic¿ connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA for: CONMED CORPORATION Utica, New York, 13502.
Code Information Lot Y101105-4
Recalling Firm/
Manufacturer		 Conmed Corporation
525 French Road
Utica NY 13502-5945
Manufacturer Reason
for Recall		 Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.
FDA Determined
Cause 2		 Other
Action On 3/08/07, "URGENT DEVICE RECALL" letters (dated 3/05/07) will be sent via UPS to the US distributors and direct user accounts. The letters inform them of the problem and of the recall. The letters instruct them to immediately discontinue using the affected lots, inspect their stocks, and to return them as soon as possible. The letters instruct the consignees to notify their customers of the recall of the devices to the user level if they have been distributed, and request the return of the products. Additionally, when requested, ConMed will notify distributor's customers (sub-accounts) by the same means. Returned devices will be automatically replaced by ConMed Corporation. A separate letter is being sent to the foreign accounts today instructing them to return the devices back to ConMed Corporation for final disposition. The letters also instruct the consignees to complete the accompanying reply form and fax it to Nancy Crisino at (315) 624-3089. ConMed has contracted Stericycle in Indianapolis, IN, to handle the recall and returns from the domestic accounts.
Quantity in Commerce 920 pairs
Distribution Worldwide, including USA, Canada, Romania, Chile, and Belgium
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 = PADPRO LLC.
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