THERAKOS DEVELOPMENT LIMITED: Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 11,499 units Lot/code info: Model/Catalog Number: CLXUSA; UDI-DI: 20705030200003; Lot Numbers: N301, N339, N340, N341, N342, N343, N344, N345, N346, N347; P302, P303, P304, P305, P306, P307, P308, P309, P310, P311, P312, P313, P314, P319, P320.

UPC codes

20705030200003

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.