FDA-Device2024-05-29Class II
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Fresenius Medical Care Holdings, Inc.
Hazard
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Sold states
US Nationwide distribution.
Affected count
12,292 units
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1868-2024Don't want to check this manually?
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