Reported May 6, 2015 · Terminated
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM,…
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- 2008
- Series Hemodialysis Machines2008K2 with the
- following product code and description190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 190628 2008K2 OLC ONLY WITH HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy
- Lot codes and dates
- Serial Numbers
178 of 178 codes
0K0S-06780K0S-08850K0S-09010K0S-09170K0S-09220K0S-09270K0S-09350K0S-09430K0S-09590K0S-09600K0S-09630K0S-09920K0S149209-1499990K0S150000-1520000K0S152001-1540000K0S154001-1600000K0S160001-1620000K0S162001-1653530S1540301K0S-10001K0S-10221K0S-10271K0S-10291K0S-10351K0S-10371K0S-1044-10461K0S-10651K0S-10671K0S-10701K0S-10941K0S-10951K0S-11021K0S-11031K0S-11211K0S165354-1741032K0S1741042K0S174105-1741112K0S174150-1821342K0S-57832K0S-58022K0S-60152K0S-60462K0S-60652K0S-60672K0S-61092K0S-62322K0S-62662K0S-95733K0S182135-1886394K0S188640-
- Serial Numbers
- Amount recalled
- 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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