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