System, Photopheresis, Extracorporeal

Brand Name: Cellex Photopheresis System

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.

Therakos Cellex Photopheresis System

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

XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT

Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits.

Therakos Cellex Procedural Kits.

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

Therakos UVAR XTS Procedural Kits

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

Therakos CellEx Photopheresis System;

Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System

Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)

Centrifuge Bowl may leak

THERAKOS CELLEX Photopheresis Procedural Kit

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

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

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.

The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA.

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.