FDA DeviceClass IINotable

FDA Recall: Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Numbe

Date: 2026-04-22
Brand: THERAKOS DEVELOPMENT LIMITED
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

5826

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