Class 2 Device Recall Therakos Photopheresis Procedural Kit for use with the UVAR XTS

• Date Initiated by Firm: July 18, 2006
• Date Posted: September 14, 2006
• Recall Status: Terminated on June 19, 2007
• Recall Number: Z-1504-06
• Recall Event ID: 35894
• PMA Number: P860003
• Product Classification: Blood collection kit - Product Code LNR
• Product: Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
• Code Information: Lot numbers U706, U707, U708, U709, U710, U711, and U712.
• Recalling Firm/ Manufacturer: Therakos Inc; 429 Creamery Way; Exton PA 19341-2508
• For Additional Information Contact: Dennis Decola; 610-280-1004
• Manufacturer Reason for Recall: Centrifuge Bowl may leak
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LNR