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Rockwell Medical, Inc recalls DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemo
Recalled May 23, 2018 · FDA recall Z-1869-2018 · Rockwell Medical
Hazard
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. · FDA Class II
Units
139
Sold at
US Distribution to the state of NY
Description
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Product
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
Manufacturer(s)
Rockwell Medical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →