Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each ...



Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Components:
Recall Date:    Apr 28, 2021
Mfg:
Fresenius Medical Care Holdings, Inc.
Mfg Country:
United States
Recall ID:    87998
Product ID:    187621
Enforcement Date:    Jul 28, 2021
Last Published:    Jul 16, 2021

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Emert Number:    Z-2084-2021
Emert Status:    Notified