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Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 2008K Series : Hemodialysis System
Recalled January 25, 2017 · FDA recall Z-1027-2017 · Fresenius Medical Care Renal Therapies Group
Hazard
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine · FDA Class II
Units
78481 (US) 2734 units (OUS)
Sold at
Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
Description
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Product
Fresenius 2008K Series : Hemodialysis System
Manufacturer(s)
Fresenius Medical Care Renal Therapies Group, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →