Reported Jul 17, 2024 · Ongoing
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - 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?
- 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part
- Model NumberF40015481 Rev A
- Lot codes and dates
- Model Number190904
- UDI/DI00840861100965
- Serial Numbers
372 of 372 codes
5K0S1941737K0S3000854K0S1903104K0S1903114K0S1903124K0S1903144K0S1903154K0S1903184K0S1903214K0S1925104K0S1925114K0S1928124K0S1928134K0S1928144K0S1928154K0S1928164K0S1928174K0S1928184K0S1928194K0S1928204K0S1928214K0S1928224K0S1928234K0S1928244K0S1928254K0S1928264K0S1928274K0S1928284K0S1928294K0S1928304K0S1928314K0S1928325K0S1941665K0S1941766K0S1720237K0S3000117K0S3000346K0S1720107K0S3000927K0S3001057K0S3000677K0S3000747K0S3000696K0S1720085K0S1941626K0S1636846K0S1720217K0S3000197K0S3000627K0S3000167K0S3000276K0S1712036K0S1694466K0S1594276K0S1670515K0S1931665K0S1941566K0S1670446K0S1670456K0S167049
- Amount recalled
- 372 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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