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Cellex Clxsp-U

by Therakos, Inc. EUDAMEDGUDID

Active European Union and United States

Ref CLXSP-UModel THERAKOS CELLEX PROCEDURAL KIT

Regulatory status

as of 26 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705030_CELLEX_EPP_Acc_3P Basic UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00705030000012 UDI-DIDate28 Feb 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

8 recalls · 3 ongoing · FDA

    • Ongoing Z-1822-2026 FDA Class II initiated 16 May 2025

    Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.

    • Ongoing Z-0567-2022 FDA Class II initiated 10 Dec 2021

    This 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 during the sterilization process and is not intended for customer use.

    • Ongoing Z-0212-2022 FDA Class II initiated 4 Oct 2021

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

    • Terminated Z-1322-2016 FDA Class II initiated 21 Dec 2015

    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.

    • Terminated Z-0595-2012 FDA Unclassified (pre-2012) initiated 1 Sep 2011

    There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System.

    • Terminated Z-2067-2011 FDA Unclassified (pre-2012) initiated 1 Feb 2011

    Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).

    • Terminated Z-2839-2011 FDA Unclassified (pre-2012) initiated 2 Dec 2010

    Cellex Procedural kits may have minor tears in their Tyvek covers.

    • Terminated Z-1504-06 FDA Unclassified (pre-2012) initiated 18 Jul 2006

    Centrifuge Bowl may leak

Specification

EUDAMED · GUDID

Trade Name
Therakos Cellex Photopheresis System Procedural Kit EUDAMED
Cellex GUDID
Generic Name
Photopheresis system
Model / Ref / Catalog
CLXSP-U, THERAKOS CELLEX PROCEDURAL KIT
Primary DI / UDI-DI
00705030000012
Basic UDI-DI
0705030_CELLEX_EPP_Acc_3P
PMA Number
FDA Product Code
LNR
EMDN Code
B030204 Extracorporeal photochemotherapy or photopheresis devices and kits
GMDN Term
Photopheresis system
Device Class
Class IIa EUDAMED
Class III GUDID
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class III

Related devices

Category: Photopheresis system

Cleared under the same submission (P860003)

Similar devices

Also classified as Photopheresis system.

Other devices from Therakos, Inc.

See all devices from Therakos, Inc. →

Properties

Show properties
  • Sterile
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No