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 Recalled by Mallinckrodt Pharmaceuticals Ireland Ltd Due to This recall was initiated to recover a Dunnage...

Date: December 10, 2021
Company: Mallinckrodt Pharmaceuticals Ireland Ltd
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 Mallinckrodt Pharmaceuticals Ireland Ltd directly.

Affected Products

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Quantity: 3

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mallinckrodt Pharmaceuticals Ireland Ltd

Mallinckrodt Pharmaceuticals Ireland Ltd has 1 total recall tracked by RecallDetector.

Related Recalls

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