Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA Recalled by Therakos, Inc. Due to Product was released prior to all testing being...

Date: October 4, 2021
Company: Therakos, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Therakos, Inc. directly.

Affected Products

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Quantity: Five (5) Cases -3 Kits/Case= 15 Kits

Why Was This Recalled?

Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.

Where Was This Sold?

This product was distributed to 1 state: IL

Affected (1 state)Not affected

About Therakos, Inc.

Therakos, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report