Class 2 Device Recall Cellex Photopheresis System

• Date Initiated by Firm: December 21, 2015
• Create Date: April 05, 2016
• Recall Status: Terminated on October 14, 2016
• Recall Number: Z-1322-2016
• Recall Event ID: 73012
• PMA Number: P860003
• Product Classification: System, photopheresis, extracorporeal - Product Code LNR
• Product: The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis
• Code Information: Mfr lot #D342
• Recalling Firm/ Manufacturer: Therakos Inc; 10 N High St; West Chester PA 19380-3003
• For Additional Information Contact: Michael Viscido; 908-238-6813
• Manufacturer Reason for Recall: The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of Kits from Lot D 342.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Therakos sent an Urgent Medical Device Recall letter dated December 23, 2015, to all affected customers by UPS Overnight Mail. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to immediately identify, discontinue use and return affected product. Customers with questions were instructed to call Therakos Customer Service at 1-855-422-9115, option 4. For questions regarding this recall call 908-238-6813.
• Quantity in Commerce: 729 units
• Distribution: Nationwide Distribution to AL, AZ, CA, CO, DC, FL, ID, IL, IN, MA, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, UT, VT, AND WI.
• 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