FDAOctober 4, 2021device
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
What to do
FDA enforcement status: Ongoing
Brands named
therakos
UPCs
20705030200003
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood v...2025-05-16
- FDAThe 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 ...2015-12-21
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