The Recall Desk
HighFDA (Devices)·Z-1322-2016·Announced 2016-04-13

Therakos CELLEX Photopheresis System Recalled for Tubing Leaks

Therakos Inc is recalling 729 units of the CELLEX Photopheresis System, Lot D342, due to an increased trend in tubing leaks within the pump tubing organizer.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (tubing leaks) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Therakos Inc is recalling 729 units of the THERAKOS CELLEX Photopheresis System, specifically Manufacturing Lot D342. This medical device is a photoimmune therapy system designed to separate a patient's blood into various fractions and treat the white blood cell fraction with a photoactive drug. The affected units were distributed nationwide to specific states including Alabama, Arizona, California, Colorado, the District of Columbia, Florida, Idaho, Illinois, Indiana, Massachusetts, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, and Wisconsin.

The recall was initiated after the post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer associated with a portion of the kits from this specific lot. The source text does not report any specific injuries, illnesses, or deaths associated with these leaks.

Healthcare facilities and consumers who have this specific lot of the CELLEX Photopheresis System should stop using it and contact Therakos Inc for further instructions on how to return or dispose of the product.

The recalled product

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 treat
Manufacturer
Therakos Inc
Category
Medical Device — Photopheresis System
Hazard
Affected units
729

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Mfr lot #D342

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Related recalls

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Same hazard · tubing leak

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