Therakos, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0212-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Product Classification:

Class II

Date Initiated: October 4, 2021

Date Posted: November 17, 2021

Recall Number: Z-0212-2022

Event ID: 88852

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.

Status: Ongoing

Product Quantity: Five (5) Cases -3 Kits/Case= 15 Kits

Code Information:

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

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated