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THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

FDA Recall #Z-0567-2022 — Class II — December 10, 2021

Recall #Z-0567-2022 Date: December 10, 2021 Classification: Class II Status: Ongoing

Product Description

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

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.

Recalling Firm

Mallinckrodt Pharmaceuticals Ireland Ltd — Dublin 15, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3

Distribution

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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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