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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