Mallinckrodt Pharmaceuticals Ireland Ltd recalls THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Recall date

December 10, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0567-2022

FDA classification

Class II

Brand / firm

Mallinckrodt Pharmaceuticals Ireland Ltd

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA