BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0823-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0823-2018
    Event ID
    79136
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    August 8, 2017
    Classification Date
    March 1, 2018
    Termination Date
    September 7, 2018
    Address
    1 Millennium Way, N/A, Branchburg, NJ, 08876-3876, United States

    Description

    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

    Code Info

    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

    Distribution

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

    Quantity

    25,798 units