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Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the prep
Recalled July 28, 2021 · FDA recall Z-2087-2021 · Fresenius Medical Care Holdings
Hazard
Exposed to freezing temperatures due to refrigerated truck malfunctions · FDA Class II
Units
120 Bags
Sold at
US Distribution to: TX only
Description
Exposed to freezing temperatures due to refrigerated truck malfunctions
Product
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is 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.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →