Z-1822-2026 Class II Ongoing
FDA device recall Z-1822-2026 was initiated by THERAKOS DEVELOPMENT LIMITED on May 16, 2025 and is designated Class II. 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 cyc… The recall status is ongoing. Affected quantity: 11,499 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2026
- Initiation Date
- May 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,499 units
Product Description
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
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Model/Catalog Number: CLXUSA; UDI-DI: 20705030200003; Lot Numbers: N301, N339, N340, N341, N342, N343, N344, N345, N346, N347; P302, P303, P304, P305, P306, P307, P308, P309, P310, P311, P312, P313, P314, P319, P320.