Z-1504-06

Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)

Name: Z-1504-06 Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
Creator: Therakos Inc
Published: 2006-07-18
License: https://open.fda.gov/license/

Therakos Inc / initiated 2006-07-18 / Terminated

FDA source

Therakos Inc began a recall of Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125) on 2006-07-18. The reason FDA records is "Centrifuge Bowl may leak". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1504-06
Status: Terminated
Initiated: 2006-07-18
Posted: 2006-09-14
Terminated: 2007-06-19
Recalling firm: Therakos Inc
Product: Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
Product code: LNR System, Photopheresis, Extracorporeal
Reason for recall: Centrifuge Bowl may leak
FDA root cause: Other
Action: The recalling firm sent a recall letter dated 7/18/06 to their customers informing them of the problem. The letter gave instructions for continued use until new kits are available.
Quantity in commerce: 1315 units
Distribution: Nationwide (including AL, AR, AZ, CA, CO, FL, GA, IL, MA, MD, MI, MO, NE, NJ, NY, OK, OR, PA, TN, TX, UT, VA, WA, and WI). Worldwide, including France, Cyprus, Hungary, Saudi Arabia, Singapore, United Kingdom, Austria, Germany, Norway, Italy, Turkey and Portugal.
Product codes and lots: Lot numbers U706, U707, U708, U709, U710, U711, and U712.

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)