FDA Medical Device Recalls (openFDA)
Therakos Inc: Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
- Recall number
- Z-1504-06
- Recalling firm
- Therakos Inc
- Product
- Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
- Status
- Terminated
- Initiated
- 2006-07-18
- Posted
- 2006-09-14
- Terminated
- 2007-06-19
- Reason
- Centrifuge Bowl may leak
- 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
- 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.
- Lot, serial or model codes
- Lot numbers U706, U707, U708, U709, U710, U711, and U712.
- 510(k) numbers
- not on file
- PMA numbers
- ["P860003"]
- Product code
- LNR
- Firm FEI
- 2523595
- Firm city
- Exton
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28