THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA — Class II medical device recall Z-0212-2022
Ongoing recall by Therakos, Inc., reported 2021-11-17, distributed in IL. Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may ca
| Recall number | Z-0212-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Therakos, Inc., West Chester, PA, United States |
| Recall initiated | 2021-10-04 |
| Classified | 2021-11-05 |
| Reported by FDA | 2021-11-17 |
| Distributed | IL |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 20705030200003 |
| Lot numbers | K307 |
| Expiration dates | 2023-02-01 |
Product
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Reason for recall
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
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-0212-2022. 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.