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U.S. Department of Health and Human Services

Class 2 Device Recall LeGoo Endovascular Occlusion Gel2.5 mL LeGoo w/ no Cannula

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  Class 2 Device Recall LeGoo Endovascular Occlusion Gel2.5 mL LeGoo w/ no Cannula see related information
Date Initiated by Firm June 21, 2013
Date Posted September 03, 2013
Recall Status1 Terminated 3 on August 07, 2014
Recall Number Z-2144-2013
Recall Event ID 65485
PMA Number P110003 
Product Classification Occluder, internal vessel, temporary - Product Code OBC
Product LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula
Product Number: PV-250

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.
Code Information All lot codes
Recalling Firm/
Manufacturer
Genzyme Corporation, A Sanofi Company
175F New Boston St
Woburn MA 01801-6203
Manufacturer Reason
for Recall
Product contains particulates (fibers)
FDA Determined
Cause 2
Material/Component Contamination
Action 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.
Quantity in Commerce 250 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OBC and Original Applicant = GENZYME CORP.
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