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UVAR XTS Procedural Kit

by Therakos Development Limited

PMA P860003

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

PMA P860003↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP860003 Date8 Apr 1987ApprovedStatusActive

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Uvar Photopheresis System
Generic Name
System, photopheresis, extracorporeal
PMA Number
FDA Product Code
LNR
Device Class
Class III
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The UVAR XTS Procedural Kit is an Extracorporeal Photopheresis System, designed for the treatment of cutaneous T-cell lymphoma and other phototherapy-responsive conditions. It employs ultraviolet A (UVA) radiation to activate leukopheresed cells, inducing apoptosis and modulating immune responses in a controlled extracorporeal setting.

This single-use kit is intended for use in clinical settings with appropriate photopheresis equipment, including a centrifuge and photoactivation module. Supplied sterile and pre-packaged, it includes all necessary consumables for one treatment session. Authorized under FDA Premarket Approval (PMA P860003), the kit adheres to Class III regulatory standards for high-risk medical devices.