| 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-1039-06 |
Recall Event ID |
35236 |
510(K)Number | K010579 |
Product Classification |
Catheter, Percutaneous - Product Code DQY
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Product | 7F ZUMA 2 SR4.0 SH 100CM
CATHETER Z27SR40SH Z2 7F 100CM SR40 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: Z27SR40SH |
Code Information |
Lot Numbers: 0000027588 0000027596 0000028599 0000183448 |
Recalling Firm/ Manufacturer |
Medtronic, Inc. 35 -37A Cherry Hill Dr Danvers MA 01923-2565
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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 | 50 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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQY
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