Reported Jul 17, 2024 · Ongoing
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - 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?
- 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part
- Model NumberF40015481 Rev A
- Lot codes and dates
- Model Number191014
- UDI/DIN/A (Canada only)
- Serial Number
6K0S1623516K0S1623526K0S1623536K0S1623546K0S1623556K0S1691136K0S1691146K0S1691156K0S1691166K0S1691176K0S1691186K0S1691196K0S1691206K0S1691216K0S1691226K0S1691236K0S1691246K0S1691256K0S1691266K0S169127
- Amount recalled
- 20 units (all OUS)
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.
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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