Reported Mar 7, 2018 · Terminated
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue…
LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC · 1 Millennium Way · Branchburg, NJ · 08876-3876
Is this the product you have?
- REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 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 - Amount recalled
- 25,798 units
Where it was sold
- Nationwide
Why it was recalled
Presence of bacterial endotoxins levels above the acceptable limit
This product could cause temporary or reversible health problems — stop using it.
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