Home / Recalls / Genzyme Corporation, A Sanofi Company / Z-2150-2013

Z-2150-2013 Class II Terminated

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

FDA device recall Z-2150-2013 was initiated by Genzyme Corporation, A Sanofi Company on June 21, 2013 and is designated Class II. Reason for recall: Product contains particulates (fibers) The recall status is terminated (terminated August 7, 2014). Affected quantity: 652 units.

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: 652 units

Product Description

LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 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)