Reported Sep 11, 2013 · Terminated
LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble,…
Genzyme Corporation, A Sanofi Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genzyme Corporation, A Sanofi Company · 175F New Boston St · Woburn, MA · 01801-6203
Is this the product you have?
- LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo
- with 3 Cannula Pouch Product NumberCS-25 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
- Lot codes and dates
- All lot codes
- Amount recalled
- 30 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Product contains particulates (fibers)
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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