Class 2 Device Recall Cellex Photopheresis System

• Date Initiated by Firm: May 16, 2025
• Date Posted: April 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1822-2026
• Recall Event ID: 98558
• PMA Number: P860003
• Product Classification: System, photopheresis, extracorporeal - Product Code LNR
• Product: Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable
• Code Information: Model/Catalog Number: CLXUSA; UDI-DI: 20705030200003; Lot Numbers: N301, N339, N340, N341, N342, N343, N344, N345, N346, N347
• FEI Number: 3036773437
• Recalling Firm/ Manufacturer: THERAKOS DEVELOPMENT LIMITED; Suite 1 Plaza 211, Blanchardstown Corporate Park 2 Blanchardstown Road North; Blanchardstown Ireland
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: On May 28, 2025 MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Determine if your facility has any of the impacted lots listed. 1. If you have received any of the kit lot numbers listed, quarantine the product and contact our Customer Care Team at 1-833-223-4ECP (1-833-223-4327) to receive instructions on how to return the affected product. 2. To report a complaint or adverse event or if you have any other questions related to the recall, please call the Customer Care Team at 1-833-223-4ECP (1-833-223-4327). Always follow the instructions for use as detailed in the Operator s Manual when installing the THERAKOS CELLEX Photopheresis System Procedural Kits. Ensuring the correct installation of the Procedural Kits is critical for system performance and avoiding treatment interruptions.
• Quantity in Commerce: 5826
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LNR