FDAFDA · Food and drugs·Recall number Z-2147-2013
LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Published September 11, 2013 · Recall initiated: June 21, 2013
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
Product contains particulates (fibers)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- Distributor
- Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
- Lot
- All lot codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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