THERAKOS CELLEX Photopheresis Procedural Kit — Class II medical device recall Z-0567-2022
Ongoing recall by Mallinckrodt Pharmaceuticals Ireland Ltd, reported 2022-02-16, distributed nationwide. This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Ca
| Recall number | Z-0567-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mallinckrodt Pharmaceuticals Ireland Ltd, Dublin 15, N/A, Ireland |
| Recall initiated | 2021-12-10 |
| Classified | 2022-02-07 |
| Reported by FDA | 2022-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Lot numbers | K341 |
Product
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Reason for recall
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.
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-0567-2022. 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.