Z-0212-2022Class II

THERAKOS CELLEX Photopheresis Procedural Kit

Name: Z-0212-2022 THERAKOS CELLEX Photopheresis Procedural Kit
Creator: Therakos, Inc.
Published: 2021-10-04
License: https://open.fda.gov/license/

Therakos Inc / initiated 2021-10-04 / Open, Classified

FDA source

Therakos, Inc. began a recall of THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA on 2021-10-04. FDA classified it as Class II and gives the reason as "Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0212-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-04
Posted: 2021-11-05
Recalling firm: Therakos Inc
Product: THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Product code: LNR System, Photopheresis, Extracorporeal
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.
FDA root cause: Under Investigation by firm
Action: Mallincrodt intiated recall by telephone on 10/04/21 and by follow-up letter. Letter states reason for recall, health risk and action to take: If you are receiving this notification, you have been identified as a customer who received CELLEX Procedural Kit Lot #K307. Immediately examine your inventory and quarantine the product subject to this recall. Mallinckrodt Pharmaceuticals will provide you with a pre-paid shipping label to return it to the Mallinckrodt Pharmaceuticals warehouse. If you have any questions regarding the return of the recalled product, please contact Mallinckrodt Pharmaceuticals at (877) 566-9466 to receive further instructions. This recall is being carried out to the direct customer level. Your assistance is appreciated. Please complete and return the enclosed response form as soon as possible.
Quantity in commerce: Five (5) Cases -3 Kits/Case= 15 Kits
Distribution: IL
Product codes and lots: LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0212-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0212-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-17	2021-11-05

Product code LNR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)