PlainRecalls
FDA Devices Moderate Class II Terminated

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 acro

Reported: July 28, 2021 Initiated: April 28, 2021 #Z-2084-2021

Product Description

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.

Reason for Recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

Details

Units Affected
(1) 40 cases (2) 3 cases (3) 4 cases
Distribution
US Distribution to: TX only
Location
Waltham, MA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: (1) 40 cases (2) 3 cases (3) 4 cases.
Why was this product recalled? ▼
Exposed to freezing temperatures due to refrigerated truck malfunctions
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2084-2021.

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