Z-1322-2016 Class II Terminated
FDA device recall Z-1322-2016 was initiated by Therakos Inc on December 21, 2015 and is designated Class II. 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. The recall status is terminated (terminated October 14, 2016). Affected quantity: 729 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2016
- Initiation Date
- December 21, 2015
- Termination Date
- October 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 729 units
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.
Distribution Pattern
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.
Code Information
Mfr lot #D342