FDA Device recall Z-1322-2016
The THERAKOS CELLEX Photopheresis System is a photoimmune therapy
- FDA Device
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of The THERAKOS CELLEX Photopheresis System is a photoimmune therapy by Therakos, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1322-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-21 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Therakos |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | Mfr lot #D342 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1322-2016%22
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