Enforcement Report - Week of October 3, 2012
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Product Detail
| Product Description | UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. |
|---|---|
| Recall Number | Z-2471-2012 |
| Classification | Class II |
| Code Info | Lot # 9374298 |
| Product Distributed Qty | 36 units |
| Reason For Recall | The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled. |
Event Detail
| Event Id | 63188 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| City | Irvine |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-09-23 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom. |
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