FDA Device Intelligence
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System, Photopheresis, Extracorporeal

FDA product code LNR · Class 3 · Unknown

12
Registered devices
2,966
Adverse events
10
Recalls
0
510(k) clearances

Devices with this code

CELLEX — Therakos LLCCELLEX — Therakos LLCCELLEX — Therakos LLCCELLEX — Therakos LLCUVAR XTS — Therakos LLCCELLEX — Therakos LLCUVAR XTS — Therakos LLCUVAR XTS — Therakos LLCCELLEX — Therakos LLCCELLEX — Therakos LLCUVAR XTS — Therakos LLCCELLEX — Therakos LLC

Recent recalls

DateFirmReason
2025-05-16THERAKOS DEVELOPMENT LIMITEDIncreased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulti
2021-12-10Mallinckrodt Pharmaceuticals Ireland LtdThis recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used dur
2021-10-04Therakos, Inc.Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
2015-12-21Therakos IncThe Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a porti
2011-09-01Therakos, Inc.There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System.
2011-03-31Therakos, Inc.Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits.
2011-02-01Therakos IncTherakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).
2010-12-02Therakos IncCellex Procedural kits may have minor tears in their Tyvek covers.
2010-03-29Therakos IncHigher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System
2006-07-18Therakos IncCentrifuge Bowl may leak

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.