Therakos Inc recalls The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030…

Recall date

December 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1322-2016

FDA classification

Class II

Brand / firm

Therakos Inc

Sold / distributed

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.

Why it was recalled

The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of Kits from Lot D 342.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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