Genzyme Corporation, A Sanofi Company
FDA Regulatory Profile
Summary
- Total Recalls
- 18
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2153-2013 | Class II | LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompati | June 21, 2013 |
| Z-2145-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGo | June 21, 2013 |
| Z-2143-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is | June 21, 2013 |
| Z-2155-2013 | Class II | LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, bioco | June 21, 2013 |
| Z-2144-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a | June 21, 2013 |
| Z-2141-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 Le | June 21, 2013 |
| Z-2140-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeG | June 21, 2013 |
| Z-2139-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGo | June 21, 2013 |
| Z-2142-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a | June 21, 2013 |
| Z-2152-2013 | Class II | LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatib | June 21, 2013 |
| Z-2146-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeG | June 21, 2013 |
| Z-2148-2013 | Class II | LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocom | June 21, 2013 |
| Z-2147-2013 | Class II | LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 Le | June 21, 2013 |
| Z-2149-2013 | Class II | LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompat | June 21, 2013 |
| Z-2154-2013 | Class II | LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocom | June 21, 2013 |
| Z-2151-2013 | Class II | LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompat | June 21, 2013 |
| Z-2156-2013 | Class II | LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, bioco | June 21, 2013 |
| Z-2150-2013 | Class II | LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompati | June 21, 2013 |