Reported May 29, 2024 · Ongoing
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, 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?
- 2008T BlueStar Hemodialysis Machine
- Model 191130 with ComponentBlood Pump Rotor
- Model NumberF40015481 Rev A
- Lot codes and dates
- ComponentModel
- NumberF40015481 Rev A
- UDI/DIN/A, All Rev A lots
- Finished DevicesModel
- Number191130
- UDI/DI00840861102112
- Serial Numbers
2,705 of 2,705 codes
2T0S2650952T0S2651312T0S2663832T0S2664062T0S2664590T0S2513280T0S2513330T0S2513340T0S2513350T0S2513370T0S2513380T0S2513430T0S2513450T0S2513470T0S2513480T0S2513490T0S2513540T0S2513630T0S2513650T0S2513680T0S2513700T0S2513750T0S2513850T0S2514010T0S2514130T0S2514190T0S2543380T0S2543850T0S2524420T0S2524510T0S2524532T0S2683933T0S2736650T0S2548840T0S2548880T0S2548934T0S2777624T0S2777654T0S2777754T0S2777854T0S2777874T0S2777914T0S2777934T0S2777954T0S2778004T0S2778014T0S2778024T0S2778064T0S2778074T0S2778084T0S2778124T0S2778174T0S2778184T0S2778214T0S2778224T0S2778314T0S2778604T0S2778693T0S2709893T0S270996
- Amount recalled
- 11,371 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 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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