---
title: "THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA — FDA record Z-0212-2022 | Is It on Recall"
description: "Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury."
url: https://isitonrecall.com/recall/fda-device-z-0212-2022-therakos-cellex-photopheresis-procedural-kit-product-code-clxusa/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA — FDA record Z-0212-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 4, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: Therakos, Inc.
- **Quantity**: Five (5) Cases -3 Kits/Case= 15 Kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0212-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0212-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

IL

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Illinois](https://isitonrecall.com/state/illinois/)

## Dates in the source

- **Report date**: Nov 17, 2021
- **Recall initiation date**: Oct 4, 2021
- **Center classification date**: Nov 5, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0212-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Therakos, Inc. records](https://isitonrecall.com/brand/therakos-inc/)