LeGoo Internal Vessel Occluder .25mL Product Number recall: Particulate Matter
LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties…
Why was LeGoo Internal Vessel Occluder .25mL Product Number recalled?
Product contains particulates (fibers)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot codes
- Product
- LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties…
- Recalling firm
- Genzyme Corporation, A Sanofi Company
- Quantity
- 448 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.
- Recall date
- September 11, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)