FDA recall Z-0212-2022

Product

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Reason for recall

Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.

Distribution

IL

Key facts

Status

Ongoing

Initiation date

2021-10-04

Report date

2021-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0212-2022