FDA Device recall Z-0567-2022
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
- FDA Device
- Class II
- ongoing
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA by Mallinckrodt Pharmaceuticals Ireland, citing 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 sterilizati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0567-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-10 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mallinckrodt Pharmaceuticals Ireland |
| Distribution | US |
Product
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Reason
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 sterilization process and is not intended for customer use.
Identifiers
| code_info | Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341 |
|---|
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-0567-2022%22
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