Recall Z-1504-06 ยท LNR System, Photopheresis, Extracorporeal
Therakos Inc
Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
| Date | Sep 14, 2006 (initiated Jul 18, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.