Reported May 6, 2015 · Terminated
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX,…
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 Machines2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic dialysis therapy
- Lot codes and dates
- Serial numbers
363 of 363 codes
0K0S1514131K0S167702-77211K0S169224-2441K0S170300-3111K0S171475-4991K0S171807-8491K0S172042-0611K0S172179-1991K0S172200-2051K0S172263-2662K0S174112-1492K0S174228-2462K0S175602-6282K0S179477-5012K0S1805122K0S1805132K0S180516-5332K0S1805422K0S1805432K0S1805462K0S1806282K0S1806292K0S181311-3322K0S181338-3402K0S181343-3472K0S181705-7193K0S182625-6593K0S183305-3243K0S183906-9203K0S183971-9803K0S184849-9123K0S185281-2843K0S185307-3113K0S185716-7453K0S185974-9893K0S185991-9983K0S186031-0453K0S186933-9623K0S186989-70024K0S1902804K0S190306-4K0S1903074K0S1903094K0S1903134K0S1903194K0S190509-5434K0S190829-8544K0S191122-1414K0S191229-2344K0S191511-5134K0S191569-5724K0S191578-5884K0S192226-2454K0S1925124K0S192514-5174K0S1925204K0S192522-5244K0S1925264K0S192528
- 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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