Reported May 6, 2015 · Terminated
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371…
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 Machines2008K with the
- following product code and description190305 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
- Lot codes and dates
- Serial Numbers
163 of 163 codes
0K0S-00090K0S-0011-00150K0S-00180K0S-00190K0S-0021-00280K0S-0030-00320K0S-0034-00360K0S-0038-00400K0S-00420K0S-0044-0770K0S-0080-2780K0S-0280-2850K0S-0287-4780K0S-0480-5520K0S-0554-6770K0S-0679-8840K0S-0886-9000K0S-0902-9160K0S-09180K0S-09200K0S-09210K0S-0923-9260K0S-0928-9340K0S-0936-9420K0S-0944-9580K0S-09610K0S-09620K0S-0964-9910K0S-0993-09991K0S-1001-49992K0S-5000-99992K0S-A000-A9992K0S-B000-B9993K0S-C000-C9993K0S-D000-
- 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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