Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysi…
- Recall date
- April 3, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1699-2019
- FDA classification
- Class III
- Brand / firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
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