THERAKOS DEVELOPMENT LIMITED is recalling 5,826 CELLEX Photopheresis Kits (Model CLXUSA) because the centrifuge bowl may be difficult to install onto its holder. If the bowl is not installed properly, it can dislodge and break during the priming or treatment phases of the procedure. This defect can lead to patient blood loss and delays in critical medical treatment.
A dislodged or broken centrifuge bowl can cause immediate blood loss for the patient and interrupt the photopheresis therapy. While no injuries have been reported, the mechanical failure of the bowl within the closed sterile circuit poses a significant risk during active blood processing.
Used with the THERAKOS Cellex Photopheresis System for extracorporeal photopheresis (ECP) therapy.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.