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Terminated

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

FDA Recall Z-1322-2016 · Posted None

Recalling FirmTherakos Inc
Recall StatusTerminated
Product CodeLNR
Date Initiated2015-12-21
Date Terminated2016-10-14
Product Quantity729 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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