Z-0567-2022Class II

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Name: Z-0567-2022 THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Creator: Mallinckrodt Pharmaceuticals Ireland Ltd
Published: 2021-12-10
License: https://open.fda.gov/license/

Mallinckrodt Pharmaceuticals Ireland Ltd / initiated 2021-12-10 / Open, Classified / root cause: sterility

FDA source

Mallinckrodt Pharmaceuticals Ireland Ltd began a recall of THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA on 2021-12-10. FDA classified it as Class II and gives the reason as "This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0567-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-10
Posted: 2022-02-07
Recalling firm: Mallinckrodt Pharmaceuticals Ireland Ltd
Product: THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Product code: LNR System, Photopheresis, Extracorporeal
Reason for recall: This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On December 10, 2021, the firm initiated phone calls to potentially affected customers. The firm identified the location of the Dunnage Case on the same day, and the Dunnage Case was returned to the recalling firm.
Quantity in commerce: 3
Distribution: US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
Product codes and lots: Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0567-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0567-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-07

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)