Recall Z-0595-2012 ยท LNR System, Photopheresis, Extracorporeal
Therakos, Inc.
Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to ot
| Date | Jan 11, 2012 (initiated Sep 1, 2011) |
| Status | Terminated |
| Reason | There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System. |
| Root cause | Other |
| Action | Therakos sent an "URGENT PRODUCT CORRECTION NOTIFICATION" dated September 1, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Additionally, a Confirmation of Receipt was attached to the letter for customers to complete and return. Contact Therakos Technical Support at 1-877-865-6850 for questions regarding this notice. |
| Quantity | 49 USA, 65 Foreign |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.