FDA Device recall Z-0212-2022
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
- FDA Device
- Class II
- ongoing
- Published 2021-11-17
On 2021-11-17 the FDA classified a Class II recall of THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA by Therakos, citing product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0212-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-04 |
| Published | 2021-11-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Therakos |
| Distribution | IL |
Product
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Reason
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
Identifiers
| code_info | LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0212-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.