Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
FDA Recall Z-1504-06 · Posted 2006-09-14
Recalling FirmTherakos Inc
Recall StatusTerminated
Product CodeLNR
Date Initiated2006-07-18
Date Terminated2007-06-19
Product Quantity1315 units
Reason for Recall
Centrifuge Bowl may leak
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.