Reported Jul 17, 2024 · Ongoing
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - 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?
- 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part
- Model NumberF40015481 Rev A
- Lot codes and dates
- Model Number190395
- UDI/DI00840861100958
- Serial Number
1,156 of 1,156 codes
6K0S-985P7K0S1077476K0S-021M7K0S1035306K0S-780R6K0S-192E6K0S-217E7K0S1029867K0S1101387K0S1101427K0S1064224K0S-P9814K0S-N1544K0S-N1574K0S-Q6975K0S-V1905K0S-V1996K0S-012R4K0S-M7054K0S-M7084K0S-N8424K0S-N8434K0S-N8464K0S-N8504K0S-N9134K0S-P2894K0S-P2904K0S-P2984K0S-P2994K0S-R0794K0S-R1064K0S-R1144K0S-R0824K0S-R1364K0S-S7074K0S-S7084K0S-S7166K0S-320H6K0S-325H6K0S-332H4K0S-S7135K0S-309C4K0S-M7034K0S-N8474K0S-R0804K0S-L7224K0S-N1524K0S-N1554K0S-N1594K0S-P2914K0S-P2944K0S-P2954K0S-Q6944K0S-Q6884K0S-R1074K0S-R0815K0S-T8914K0S-R1357K0S1063755K0S-168D
- Amount recalled
- 1,156 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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