FDAClass IINovember 17, 2021

THERAKOS CELLEX Photopheresis Procedural Kit recall

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Why was THERAKOS CELLEX Photopheresis Procedural Kit 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Recalling firm
Therakos, Inc.
Quantity
Five (5) Cases -3 Kits/Case= 15 Kits
Distribution
IL
Recall date
November 17, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls