# P860003: Uvar Photopheresis System

- Pathway: PMA
- Applicant: Therakos Development Limited
- Decided: Apr 8, 1987 after 439 days
- Product code: LNR (System, Photopheresis, Extracorporeal)
- Device class: 3
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 16, 2025 · Class II · Z-1822-2026: 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 cyc
- Dec 10, 2021 · Class II · Z-0567-2022: 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
- Oct 4, 2021 · Class II · Z-0212-2022: Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
- Dec 21, 2015 · Class II · Z-1322-2016: 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.
- Sep 1, 2011 · Not classified · Z-0595-2012: There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System.
- Feb 1, 2011 · Not classified · Z-2067-2011: Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).
- Dec 2, 2010 · Not classified · Z-2839-2011: Cellex Procedural kits may have minor tears in their Tyvek covers.
- Jul 18, 2006 · Not classified · Z-1504-06: Centrifuge Bowl may leak

Source page: https://510kreport.com/device/P860003
Methodology: https://510kreport.com/methodology