FDA recall Z-0567-2022

Product

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2021-12-10

Report date

2022-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dublin 15, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0567-2022