Rockwell Medical, Inc recalls DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodi…
- Recall date
- April 7, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1869-2018
- FDA classification
- Class II
- Brand / firm
- Rockwell Medical, Inc
- Sold / distributed
- US Distribution to the state of NY
Why it was recalled
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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