|
Class 2 Device Recall Medtronic |
|
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/ 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 |
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
|
|
|
|