Recall Z-2155-2013
Genzyme Corporation, A Sanofi Company · initiated June 21, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT 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.
Codes / lots: All lot codes
Reason for recall
Product contains particulates (fibers)
FDA-determined cause: Material/Component Contamination
Action taken
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087. For questions regarding this recall call 508-270-2285.
Details
- Recall number
- Z-2155-2013
- Initiated
- June 21, 2013
- Posted by FDA
- September 3, 2013
- Terminated
- August 7, 2014
- Product code
- OBC – Occluder, Internal Vessel, Temporary
- Quantity
- 220 units
- Distribution
- 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.
- Recalling firm
- Genzyme Corporation, A Sanofi Company, Woburn, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2139-2013 Class II | LeGoo Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number:…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2140-2013 Class II | LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2141-2013 Class II | LeGoo Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number:…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2142-2013 Class II | LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2143-2013 Class II | LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2144-2013 Class II | LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2145-2013 Class II | LeGoo Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2146-2013 Class II | LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number:…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2147-2013 Class II | LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2148-2013 Class II | LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2149-2013 Class II | LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2150-2013 Class II | LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2151-2013 Class II | LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2152-2013 Class II | LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2153-2013 Class II | LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2154-2013 Class II | LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble…Product contains particulates (fibers) | 06/21/2013Terminated |
| Z-2156-2013 Class II | LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a…Product contains particulates (fibers) | 06/21/2013Terminated |