Therakos Recalls | RecallPedia

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Class I - Dangerous

Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.

Oct 4, 2021 Other Medical Devices View Details →

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

Class I - Dangerous

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.

Dec 21, 2015 Infusion Pumps Nationwide View Details →