Therakos UVAR XTS Procedural Kits recallZ-2067-2011 · Therakos Inc · initiated Feb 1, 2011
Terminated All recalls posted in April 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Therakos Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2067-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 1, 2011
- Posted by the FDA
- Apr 28, 2011
- Recalling firm
- Therakos Inc
- Quantity
- 4,323 kits
- Product code
- LNR
- FDA submissions
- P860003
- Distribution
- Worldwide Distribution
Product description
Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
2 devices cleared under P860003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CELLEX CLXSP-ITherakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL23 reports
- CELLEX CLXCC-ITherakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page