Reported Feb 12, 2014 · Terminated

Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket…

Fresenius Medical Care Holdings, 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: Fresenius Medical Care Holdings, Inc. · 920 Winter St · Waltham, MA · 02451-1521

Is this the product you have?

  • Fresenius Bicarbonate Jug Adapter to the 2008
  • Series Hemodialysis machine Part Number650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container
Amount recalled
703 units

Where it was sold

  • Nationwide

Why it was recalled

Bicarbonate Jug Adapter distributed prior to 510(k) approval

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 May 18, 2021 · Data as of Sep 19, 4:53 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.