FDA-Device2022-02-16Class II
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Mallinckrodt Pharmaceuticals Ireland Ltd
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
Affected count
3
Manufactured in
College Business & Technology Park, Blanchardstown Road North, Dublin 15, N/A, Ireland
Products
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0567-2022Don't want to check this manually?
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