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CELLEX
Therakos LLC · Model CLXSP-I · UDI-DI 00705030000005
LNR
Prescription
0
510(k) clearances
2,966
Adverse events (37 deaths)
10
Recalls
10
Facilities
Description
CellEx Procedural Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-16 | THERAKOS DEVELOPMENT LIMITED | 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 |
| 2021-12-10 | Mallinckrodt Pharmaceuticals Ireland Ltd | This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilizatio |
| 2021-10-04 | Therakos, Inc. | Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury. |
| 2015-12-21 | Therakos Inc | 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 |
| 2011-09-01 | Therakos, Inc. | There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System. |
| 2011-03-31 | Therakos, Inc. | Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits. |
| 2011-02-01 | Therakos Inc | Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125). |
| 2010-12-02 | Therakos Inc | Cellex Procedural kits may have minor tears in their Tyvek covers. |
| 2010-03-29 | Therakos Inc | Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System |
| 2006-07-18 | Therakos Inc | Centrifuge Bowl may leak |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.