Reported Jun 23, 2021 · Terminated

Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a…

Medivators, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medivators, Inc. · 14605 28th Ave N · Plymouth, MN · 55447-4822

Is this the product you have?

  • Dialysate Concentrate for Hemodialysis-Liquid/Powd -
  • Product Usageused in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine
Lot codes and dates
  • Lot 489224
Amount recalled
1,381 CASES

Where it was sold

Why it was recalled

The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 11, 2024 · Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.