Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
FDA device recall Z-1504-06 · posted 2006-09-14 · Terminated
Recall details
- Recalling firm
- Therakos Inc
- Reason for recall
- Centrifuge Bowl may leak
- Action taken
- 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
- Status
- Terminated
- Product code
- LNR
- Quantity affected
- 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
- Date initiated
- 2006-07-18
- Date posted
- 2006-09-14
- Date terminated
- 2007-06-19
- Location
- Exton, PA
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