Recall Z-1822-2026 ยท LNR System, Photopheresis, Extracorporeal
THERAKOS DEVELOPMENT LIMITED
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 (U
| Date | Apr 16, 2026 (initiated May 16, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 O |
| Quantity | 11,499 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.