Recall Z-1322-2016— Therakos Inc
Class II · Terminated
Class II FDA medical device recall by Therakos Inc, initiated 2015-12-21, terminated 2016-10-14. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Therakos Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-21
- Terminated
- 2016-10-14
- Firm location
- West Chester, PA, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.