CLASS II ONGOING Device recall · Reported 16 Feb 2022 · FDA Enforcement Report

Therakos Cellex Photopheresis Procedural Kit, Clxusa recalled

Mallinckrodt Pharmaceuticals Irel is recalling Therakos Cellex Photopheresis Procedural Kit, Clxusa, distributed nationwide in the US. The recall was initiated on 10 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341

Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0567-2022
FDA event ID: 89383
Recalling firm: Mallinckrodt Pharmaceuticals Irel, Dublin 15, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 10 Dec 2021
FDA classified: 7 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Other Medical Devices

Timeline

10 Dec 2021	Recall initiated by company
7 Feb 2022	Classified by FDA	+59 days
16 Feb 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Where it was distributed

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

Nationwide California Florida Georgia Massachusetts Michigan North Carolina New Jersey New York Ohio Tennessee Texas Virginia West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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