Therakos Photopheresis Procedural Kit for use with the UVAR… recallZ-1504-06 · Therakos Inc · initiated Jul 18, 2006
Terminated All recalls posted in September 2006
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
Centrifuge Bowl may leak
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1504-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 18, 2006
- Posted by the FDA
- Sep 14, 2006
- Recalling firm
- Therakos Inc
- Quantity
- 1315 units
- Product code
- LNR
- FDA submissions
- P860003
- 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 description
Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
Code information (models, lots, serial numbers)
Lot numbers U706, U707, U708, U709, U710, U711, and U712.
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.
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