Reported Jun 12, 2019 · Terminated

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T…

Fresenius Medical Care Renal Therapies Group, LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 Renal Therapies Group, LLC · 920 Winter St · Waltham, MA · 02451-1521

Is this the product you have?

  • 2008T BlueStar Machine Software v.2.72-Hemodialysis
  • machine Model Number191126 -
  • Product UsageThe 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility
Lot codes and dates
  • Software v.2.72
Amount recalled
257 units

Where it was sold

  • Nationwide

Why it was recalled

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 30, 2019 · Data as of Sep 19, 3:27 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.