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U.S. Department of Health and Human Services

Class 2 Device Recall REVOLVE ADVANCED ADIPOSE SYSTEM

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  Class 2 Device Recall REVOLVE ADVANCED ADIPOSE SYSTEM see related information
Date Initiated by Firm August 08, 2017
Create Date March 01, 2018
Recall Status1 Terminated 3 on September 07, 2018
Recall Number Z-0823-2018
Recall Event ID 79136
510(K)Number K120902  
Product Classification System, suction, lipoplasty - Product Code MUU
Product REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Code Information 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 
Recalling Firm/
Manufacturer		 LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
1 Millennium Way
Branchburg NJ 08876-3876
For Additional Information Contact
908-947-1100
Manufacturer Reason
for Recall		 Presence of bacterial endotoxins levels above the acceptable limit
FDA Determined
Cause 2		 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: complaintfeedbackregistration@lifecell.com For Credit or
Quantity in Commerce 25,798 units
Distribution US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUU and Original Applicant = THE GID GROUP, INC.
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