Z-2067-2011

Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation

Name: Z-2067-2011 Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation
Creator: Therakos Inc
Published: 2011-02-01
License: https://open.fda.gov/license/

Therakos Inc / initiated 2011-02-01 / Terminated / root cause: manufacturing process

FDA source

Therakos Inc began a recall of Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation on 2011-02-01. The reason FDA records is "Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2067-2011
Status: Terminated
Initiated: 2011-02-01
Posted: 2011-04-28
Terminated: 2014-03-13
Recalling firm: Therakos Inc
Product: Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.
Product code: LNR System, Photopheresis, Extracorporeal
Reason for recall: Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Therakos notified all direct Therakos US and ex-US End Users and Distributor consignees via Federal Express courier with an Urgent Product Correction Notification, dated 2/1/2011. The letter identified the reason for recall along with the affected product. Customers were to immediately discontinue using and discard the identified affected lots of the product. Customers were to use alternative lots. In order to receive credit for the discarded product, customers were to complete the attached confirmation of receipt and destruction. If there were any questions, a question and answer section was provided but additional questions could be directed towards Therakos Customer Service Center at 1-800-828-6316, Option 2,1.
Quantity in commerce: 4,323 kits
Distribution: Worldwide Distribution
Product codes and lots: Lots Y703 through Y707 and Y709 though Y726 Lot Number - Expiration Date Y703, 1/1/2015 Y704, 2/1/2015 Y705, 2/1/2015 Y706, 2/1/2015 Y707, 2/1/2015 Y709, 2/1/2015 Y710, 3/1/2015 Y711, 3/1/2015 Y712, 3/1/2015 Y713, 3/1/2015 Y714, 3/1/2015 Y715, 3/1/2015 Y716, 3/1/2015 Y717, 4/1/2015 Y718, 4/1/2015 Y719, 4/1/2015 Y720, 4/1/2015 Y721, 4/1/2015 Y722, 4/1/2015 Y723, 4/1/2015 Y724, 4/1/2015 Y725, 5/1/2015; and Y726, 5/1/2015.

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)