Home / Recalls / Genzyme Corporation, A Sanofi Company / Z-2146-2013

Z-2146-2013 Class II Terminated

Recalled by Genzyme Corporation, A Sanofi Company — Woburn, MA

Recall Details

Product Type
Devices
Report Date
September 11, 2013
Initiation Date
June 21, 2013
Termination Date
August 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
994 units

Product Description

LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 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.

Reason for Recall

Product contains particulates (fibers)

Distribution Pattern

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.

Code Information

All lot codes

Other recalls by Genzyme Corporation, A Sanofi Company

  • Z-2153-2013 Class II — LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water (June 21, 2013)
  • Z-2145-2013 Class II — LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product (June 21, 2013)
  • Z-2143-2013 Class II — LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: (June 21, 2013)
  • Z-2155-2013 Class II — LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a (June 21, 2013)
  • Z-2144-2013 Class II — LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV (June 21, 2013)
  • Z-2141-2013 Class II — LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product N (June 21, 2013)
  • Z-2140-2013 Class II — LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product N (June 21, 2013)
  • Z-2139-2013 Class II — LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Nu (June 21, 2013)
  • Z-2142-2013 Class II — LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: (June 21, 2013)
  • Z-2152-2013 Class II — LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water- (June 21, 2013)