Company: Fresenius Medical Care Renal Therapies Group, LLC
Date of Enforcement Report: 6/12/2019
Class III
PRODUCT
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.
Recall Number: Z-1699-2019
REASON
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
RECALLING FIRM/MANUFACTURER
Fresenius Medical Care Renal Therapies Group, LLC on 4/3/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
257 units
DISTRIBUTION
US Nationwide