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

Recall Z-1859-2021 — Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

U.S. FDA — Device Enforcement · United States · 2021-04-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1859-2021
Date of alert
2021-04-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medivators, Inc.
Product category
device
Product type
Devices
Reported risk: The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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