# FDA recall Z-0567-2022

> **Mallinckrodt Pharmaceuticals Ireland Ltd** · Class II · device recall initiated 2021-12-10.

## 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.

## Distribution

US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.

## Key facts

- **Recall number:** Z-0567-2022
- **Recalling firm:** Mallinckrodt Pharmaceuticals Ireland Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-10
- **Report date:** 2022-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin 15, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0567-2022

## Citation

> AI Analytics. FDA recall Z-0567-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0567-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*