FDA-Device2018-03-07Class II
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
Hazard
Presence of bacterial endotoxins levels above the acceptable limit
Sold states
US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore
Affected count
25,798 units
Manufactured in
1 Millennium Way, N/A, Branchburg, NJ, United States
Products
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0823-2018Don't want to check this manually?
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