Recall Z-0823-2018— LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
Class II · Terminated
Class II FDA medical device recall by LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC, initiated 2017-08-08, terminated 2018-09-07. It names one FDA 510(k) clearance: K120902. Product: REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.. Reason: Presence of bacterial endotoxins levels above the acceptable limit.
- Recalling firm
- LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-08
- Terminated
- 2018-09-07
- Firm location
- Branchburg, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.