Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1869-2018 — 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.

U.S. FDA — Device Enforcement · United States · 2018-04-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1869-2018
Date of alert
2018-04-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Rockwell Medical, Inc
Product category
device
Product type
Devices
Reported risk: A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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