Skip to content
Recall Observatory FDA recall evidence

Device product

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Z-0212-2022

October 04, 2021

Class II

Product summary

Firm
Therakos, Inc.
Event
Event 88852
Status
Ongoing
Classification
Class II
Quantity
Five (5) Cases -3 Kits/Case= 15 Kits
Official record key
device-enforcement:Z-0212-2022

Official wording

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

Code information: LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201

Distribution pattern: IL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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