Reported Apr 13, 2016 · Terminated
The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI:…
Therakos Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Therakos Inc · 10 N High St · West Chester, PA · 19380-3003
Is this the product you have?
- The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA
- Manufacturing lot D342 UDI20705030200003 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
- Lot codes and dates
- Mfr lot #D342
- Amount recalled
- 729 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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