Recall Z-0823-2018 ยท MUU System, Suction, Lipoplasty
LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
| Date | Aug 8, 2017 |
| Status | Terminated |
| Reason | Presence of bacterial endotoxins levels above the acceptable limit |
| Root cause | Material/Component Contamination |
| Action | The firm's initial notice to customers (dated May 25, 2017) advising customers that Allergan has placed a hold on shipping the device until verification is complete. Within this notice, customers were advised to continue use of the product. On June 14, 2017, a second notice was issued to customers informing customers that product shipments will resume by August 1, 2017 and that manufacturing process improvements will be implemented. On August 8, 2017, Allergen distributed URGENT MEDICAL DEVICE RECALL notices and Business Reply Forms (dated August 2, 2017) to US customers advising them to t |
| Quantity | 25,798 units |
| Distribution | US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120902 | GID 700 The Gid Group, Inc., Aug 15, 2012 |