Reported Jul 17, 2024 · Ongoing
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
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 Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
- 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part
- Model NumberF40015481 Rev A
- Lot codes and dates
- Model Number190828
- UDI/DI00840861100941
- Serial Numbers
531 of 531 codes
2K0S1794893K0S1848853K0S1857441K0S1720501K0S1722021K0S1718231K0S1720563K0S1859893K0S1860384K0S1908494K0S1911321K0S1718464K0S1925324K0S1925344K0S1922324K0S1915832K0S1806293K0S1857384K0S1905171K0S1714881K0S1722664K0S1927363K0S1857303K0S1857323K0S1857343K0S1857403K0S1869553K0S1870004K0S1905094K0S1905144K0S1905154K0S1905194K0S1905254K0S1905374K0S1915114K0S1915714K0S1915784K0S1925144K0S1925204K0S1925224K0S1925234K0S1925284K0S1925384K0S1922354K0S1922314K0S1922364K0S1922372K0S1805212K0S1805222K0S1805273K0S1860363K0S1826263K0S1826273K0S1826373K0S1826463K0S1849103K0S1857193K0S1857213K0S1857393K0S185742
- Amount recalled
- 531 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
This product could cause temporary or reversible health problems — stop using it.
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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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