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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-1001-06
Recall Event ID 35236
510(K)Number K021256  
Product Classification Catheter, Percutaneous - Product Code DQY
Product CATHETER SB63DRC SB 6F 100CM 3
CATHETER SB63DRC SB 6F 100CM 3DRC 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 Code: SB63DRC

Code Information Lot Numbers: 0000055758 0000055759 0000055760 0000070849 0000071307 0000071309 0000073024 0000073025 0000075756 0000080599 0000082939 0000093035 0000096718 0000097929 0000100993 0000103729 0000110816 0000113625 0000114979 0000126421 0000130789 0000134456 0000141335 0000148442 0000149211 0000154614 0000173136 0000173875 0000175333 
Recalling Firm/
Medtronic, Inc.
35 -37A Cherry Hill Dr
Danvers MA 01923-2565
For Additional Information Contact Fred Boucher
Manufacturer Reason
for Recall
Potential for non-sterility due to loss of package integrity
FDA Determined
Cause 2
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 341units
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