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Fresenius Medical Care Holdings, Inc. recalls 2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371
Recalled May 6, 2015 · FDA recall Z-1551-2015 · Fresenius Medical Care Holdings
Hazard
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen. · FDA Class II
Units
133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)
Sold at
Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
Description
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
Product
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →