Reported May 6, 2015 · Terminated
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home 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 Machines2008T with the
- following product code and description190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy
- Lot codes and dates
- Serial Numbers
0T0S100031- 1013581T0S101359- 1279382T0S109489- 1181303T0S118131- 1261634T0S126164- 1354089T0S1000029T0S1000049T0S100007- 1000109T0S1000129T0S100014- 100016
- 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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