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Renasol Bicarbonate Concentrate Powder

MEDIVATORS INC. · Model BC-1 · UDI-DI 00677964000331

FKQ
10
510(k) clearances
19
Adverse events (4 deaths)
2
Recalls
6
Facilities

Description

Renasol Bicarbonate Concentrate Powder

Recalls

DateFirmReason
2021-04-20Medivators, Inc.The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
2013-03-01B. Braun Medical, Inc.There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration c

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.