FDAFDA · Food and drugs·Recall number Z-2472-2012
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the 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.
Published October 3, 2012 · Recall initiated: September 23, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Distributor
- 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.
- Lot
- Lot # 9374210
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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