Therakos Inc
West Chester, PA, US
Therakos Inc appears in FDA device records in West Chester, PA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 8 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 8
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0212-2022 | THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA | Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury. | Class II | Open, Classified | |
| Z-1322-2016 | The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis | 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. | Class II | Terminated | |
| Z-0595-2012 | 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 other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use. | There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System. | Terminated | ||
| Z-2994-2011 | XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittenly returns the remaining plasma and erythocytes to the patient. | Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits. | Terminated | ||
| Z-2067-2011 | Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation. | Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125). | Terminated | ||
| Z-2839-2011 | Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit. | Cellex Procedural kits may have minor tears in their Tyvek covers. | Terminated | ||
| Z-1654-2010 | Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument; | Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System | Terminated | ||
| Z-1504-06 | Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125) | Centrifuge Bowl may leak | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain