FDAClass IIFebruary 16, 2022

THERAKOS CELLEX Photopheresis Procedural Kit recall

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Why was THERAKOS CELLEX Photopheresis Procedural Kit 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Recalling firm
Mallinckrodt Pharmaceuticals Ireland Ltd
Quantity
3
Distribution
US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
Recall date
February 16, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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