PlainRecalls
FDA Devices Moderate Class II Ongoing

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Reported: November 17, 2021 Initiated: October 4, 2021 #Z-0212-2022

Product Description

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.

Details

Recalling Firm
Therakos, Inc.
Units Affected
Five (5) Cases -3 Kits/Case= 15 Kits
Distribution
IL
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA. Recalled by Therakos, Inc.. Units affected: Five (5) Cases -3 Kits/Case= 15 Kits.
Why was this product recalled?
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 17, 2021. Severity: Moderate. Recall number: Z-0212-2022.