Recall Z-1322-2016 ยท LNR System, Photopheresis, Extracorporeal
Therakos Inc
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
| Date | Dec 21, 2015 |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.