Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact THERAKOS DEVELOPMENT LIMITED or your healthcare provider for instructions. Notification method: E-Mail
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Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable. Reason: Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.. Classification: Class II. Quantity: 5826. Distribution: US Nationwide distribution.
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