Z-0823-2018Class II

REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous...

Name: Z-0823-2018 REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous...
Creator: LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
Published: 2017-08-08
License: https://open.fda.gov/license/

LifeCell Corp / initiated 2017-08-08 / Terminated / root cause: manufacturing process

FDA source

LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC began a recall of REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring on 2017-08-08. FDA classified it as Class II and gives the reason as "Presence of bacterial endotoxins levels above the acceptable limit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0823-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-08
Posted: 2018-03-01
Terminated: 2018-09-07
Recalling firm: LifeCell Corp
Product: REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Product code: MUU System, Suction, Lipoplasty
Reason for recall: Presence of bacterial endotoxins levels above the acceptable limit
Root cause tag: manufacturing process
FDA 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 take the following Actions: Actions to be taken 1. Immediately examine your inventory and quarantine all product subject to this recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall, and that all product should be quarantined. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 2. Carry out a physical count of the affected product in your possession and record the count on the enclosed postage paid Business Reply Form (BRF) and Packing slip. 3. Mail the postage paid BRF immediately. To assure that we can account for all recalled product, it is imperative that you return the BRF. 4. When returning the recalled product, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton. Return the recalled product and completed Packing Slip to: GENCO Pharmaceutical Services (GPS), a subsidiary of FedEx Supply Chain 6101 North 64th Street, Milwaukee, WI 53218 For Product Returns: Contact Genco Pharmaceutical Services, a subsidiary of FedEx Supply Chain at: 1-877-319-8961 during the hours of 7 AM - 5 PM CST. For Adverse Events/Product Complaints: Contact LifeCell at 1-800-367-5737, during the hours of 9 AM - 5 PM EST or via Email: [email protected] For Credit or
Quantity in commerce: 25,798 units
Distribution: US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore
Product codes and lots: Lot Number/Expiration Dates: 1) 10565 & 10641 - 5/31/2017 2) 10651, 10658, 10626 & 10628 - 6/30/2017 3) 10642, 10630, 10643, 10629, 10631 - 7/31/2017 4) 10669, 10633, 10634 & 10635 - 8/31/2017 5) 10636 & 10637 - 9/30/2017 6) 10736, 10693, 10695 & 10694 -10/31/2017 7) 10698, 10699, 10696 & 10697 -11/30/2017 8) 10700, 10701 & 10702 - 12/31/2017 9) 10704, 10705, 10703 & 10799 -1/31/2018 10) 10706, 10708 & 10785 - 2/28/2018 11) 10791, 10792, 10786, 10787 & 10707 - 3/31/2018 12) 10838, 10793, 10795, 10794 & 10788 - 4/30/2018 13) 10789, 10840 & 10796 - 5/31/2018 14) 10841, 10709, 10825 & 10782 - 6/30/2018 15) 10826, 10827 & 10783 - 7/31/2018 16) 11222, 11224, 11234, 11235, 11223, 11225, 11089, 11246, 10790, 10830, 11208, 11210, 11214, 11215, 11209, 11217, 11211, 11216, 11212, 11213, 11226, 11229, 11227 &11228 - 8/31/2018 17) 11236, 11237, 11247, 11232, 11230, 11233, 11219, 11231, 11262 & 11085 - 9/30/2018 18) 11553, 11554, 11252, 11556, 11087, 11555, 11090, 11249, 11253, 3038912, 11254, 3038910 & 3097870 - 10/31/2018 19) 11250, 11251, 11325, 11324, 11560 & 3103907 - 11/30/2018 20) 11326, 11328, 11327, 11331, 11329, 11330, 11820, 11819, 11578, 11821, 11822 & 11579 -1/31/2019 21) 11256, 11255, 11088, 11257, 11852, 11853 & 11854- 2/28/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0823-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0823-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code MUU

K120902Class IIGid 700The Gid Group, Inc. / cleared 2012-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)