FDA-Device2018-05-23Class II
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.
Rockwell Medical, Inc
Hazard
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Sold states
US Distribution to the state of NY
Affected count
139
Manufactured in
30142 S. Wixom Rd., Wixom, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1869-2018Don't want to check this manually?
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