The THERAKOS CELLEX Photopheresis System is a photoimmune therapy — Class II medical device recall Z-1322-2016
Terminated recall by Therakos Inc, reported 2016-04-13, distributed nationwide. The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within
| Recall number | Z-1322-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Therakos Inc, West Chester, PA, United States |
| Recall initiated | 2015-12-21 |
| Classified | 2016-04-05 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-10-14 |
| Distributed | Nationwide (US) |
| Quantity | 729 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 20705030200003 |
| Lot numbers | D342 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1322-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.