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Genzyme Corporation, A Sanofi Company recalls LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with re
Recalled September 11, 2013 · FDA recall Z-2151-2013 · Genzyme Corporation, A Sanofi
Hazard
Product contains particulates (fibers) · FDA Class II
Units
331 units
Sold at
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.
Description
Product contains particulates (fibers)
Product
LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 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.
Manufacturer(s)
Genzyme Corporation, A Sanofi Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →