Therakos Inc: Medical Device Recall in 2016 - (Recall #: Z-1322-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 21, 2015

Date Posted: April 13, 2016

Recall Number: Z-1322-2016

Event ID: 73012

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.

Status: Terminated

Product Quantity: 729 units

Code Information:

Mfr lot #D342

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.

Voluntary or Mandated:

Voluntary: Firm initiated