Reported Feb 4, 2015 · Terminated

ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K…

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?

  • ASSY, POWER SUPPLY 130V 50HZ. This component
  • is used with the following machines2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Lot codes and dates
    • 4P¿226813
    • 4P¿226815
    • 4P-226817
    • 4P-226818
    • 4P¿226819
    • 4P-226820
    • 4P-226821
    • 4P-226822
Amount recalled
10

Where it was sold

Why it was recalled

Unqualified power assemblies shipped to customers.

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 Jan 29, 2021 · Data as of Sep 19, 6:01 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.