COOLSCULPTING, specific serials.

The ZELTIQ system provides a non-invasive method of reducing fat layers using controlled cooling in a precise and paramedical manner: volume of tissue visibly increased in size within the treatment zone, which can develop two to five months after treatment. A surgical intervention may be necessary.

Cooling pack

Model: , Affected: 85422, 86516, 87052, 87437

md

md

md

md

md

medical_device

Lot # Serial # Style #: 1703043, 14124459, MSZFX410; 1708499, 14164655, MSZFX410; 1801072, 14768661, MSZFX410; 1819375, 14905528, MSZFX410; 1819377, 14911183, MSZFX410; 1819377, 14911197, MSZFX410; 1819377, 14911180, MSZFX410; 1819378, 14907262, MSZFX410; 1819378, 14907266, MSZFX410.

General and Plastic Surgery Devices

Unclassified

No

CA, IN, MO, NJ, VA

Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. || The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.

Injections / Infusions / Transfusions / Dialysis

Injections / Infusions / Transfusions / Dialysis - drainages and suction systems

Revolve Advanced Adipose System (Revolve System)    , Lifecell Corporation

Disposable products

Products-by-biological origin

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

General and Plastic Surgery Devices

2

No

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

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

Allergan: Allergan Breast Implants and Tissue Expanders

Allergan Limited: NATRELLE® Re-Sterilizable Breast Implant Sizers

Lifecell: Revolve™ System

Lifecell Corporation: Strattice reconstructive tissue matrix

see FSN

MD: Tissue expander