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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm April 05, 2006
Date Posted June 01, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-0943-06
Recall Event ID 35236
510(K)Number K021256  
Product Classification Catheter, Percutaneous - Product Code DQY
Product CATH. GUIDE 6F EBU4.0 110CM LA
CATHETER LA6EBU40A LA 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system.
Product Number: LA6EBU40A
Code Information Lot Numbers: 0000012692 0000017476 0000052795 
Recalling Firm/
Manufacturer		 Medtronic, Inc.
35 -37A Cherry Hill Dr
Danvers MA 01923-2565
For Additional Information Contact Fred Boucher
978-739-3116
Manufacturer Reason
for Recall		 Potential for non-sterility due to loss of package integrity
FDA Determined
Cause 2		 Other
Action Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Quantity in Commerce 47 units
Distribution Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
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 = DQY and Original Applicant = MEDTRONIC VASCULAR
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