Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog Recalled by Therakos Inc Due to The Mallinckrodt (Therakos) post-market monitoring process detected an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Therakos Inc directly.
Affected Products
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
Quantity: 729 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Therakos Inc
Therakos Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report