FDA-Device2024-07-17Class II
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, 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
Domestic: Nationwide Distribution. International: Canada.
Affected count
2 units
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2346-2024Don't want to check this manually?
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