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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis ADROIT 6F Guiding Catheter

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 Class 2 Recall
Cordis ADROIT 6F Guiding Catheter
see related information
Date Posted October 01, 2013
Recall Status1 Terminated on September 30, 2014
Recall Number Z-0003-2014
Recall Event ID 66026
Premarket Notification
510(K) Number
K131225 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Code Information Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323
Recalling Firm/
Manufacturer
Cordis Corporation
14201 Nw 60th Ave
Miami Lakes, Florida 33014-2802
For Additional Information Contact Customer Service
800-551-7683
Manufacturer Reason
for Recall
Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Cordis sent an Urgent Medical Device Recall letter dated August 12, 2013 Acknowledgement Form to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected product in a manner that ensures the product will not be used. Customers were asked to review, complete, sign and return the enclosed Acknowledgement form directly to Cordis to the fax number on the form. For questions call the Customer Service number at 800-561-7683.
Quantity in Commerce 1238 units
Distribution Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = CORDIS CORP., A JOHNSON & JOHNSON CO.
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