FDA recall Z-0823-2018

LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC · Class II · device

Product

REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

Reason for recall

Presence of bacterial endotoxins levels above the acceptable limit

Distribution

US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore

Key facts

Status
Terminated
Initiation date
2017-08-08
Report date
2018-03-07
Termination date
2018-09-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Branchburg, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0823-2018