CELLEX PHOTOPHERESIS SYSTEM

Mfr lot #D342

Gastroenterology-Urology Devices

3

No

Nationwide Distribution to AL, AZ, CA, CO, DC, FL, ID, IL, IN, MA, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, UT, VT, AND WI.

The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. || Manufacturing lot D342 || UDI: 20705030200003 || The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis

Medical Device Safety Alert: Therakos, Inc. CELLEX Photopheresis System

Therakos CELLEX Photopheresis System, Therakos Inc.

all

MD: Photopheresis system blood set

CLXUSA (US): Lot X120, Exp 12/10; X123, Exp 1/2011; Lot Y106, Exp 2/1/11. CLSECP (For European Union), Lot X119, Exp 12/2014; Lot X123; Exp 1/2015

Gastroenterology-Urology Devices

3

No

Nationwide Distribution, and Canada and Germany

Therakos CellEx Photopheresis System; || Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;