Rockwell Medical, Inc recalls DriSate¿ Product Code DR-145 The acid concentrate powders
Recalled 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.
Hazard / Issue
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Issued by
FDA
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