LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, bioco

FDA device recall Z-2140-2013 · posted 2013-09-03 · Terminated

Recall details

Recalling firm

Genzyme Corporation, A Sanofi Company

Reason for recall

Product contains particulates (fibers)

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

OBC

Quantity affected

65 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 Arabi

Date initiated

2013-06-21

Date posted

2013-09-03

Date terminated

2014-08-07

Location

Woburn, MA