Reported May 29, 2024 · Ongoing
2008T BlueStar Hemodialysis Machine, Model 191126 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 191126 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
- Number191126
- UDI/DI00840861102099
- Serial Numbers
2,705 of 2,705 codes
3T0S2706873T0S2707003T0S2740073T0S2740093T0S2740113T0S2740123T0S2740163T0S2740573T0S2748593T0S2749203T0S2749223T0S2749233T0S2749383T0S2749573T0S2749693T0S2749703T0S2749803T0S2749853T0S2749963T0S2749973T0S2750043T0S2750093T0S2750111T0S2622261T0S2622491T0S2622541T0S2622571T0S2622651T0S2622661T0S2622671T0S2622681T0S2622691T0S2622721T0S2622731T0S2622741T0S2622751T0S2622761T0S2622781T0S2622791T0S2622801T0S2622821T0S2622831T0S2622841T0S2622851T0S2622861T0S2622891T0S2622931T0S2622941T0S2622961T0S2622971T0S2622991T0S2623001T0S2623051T0S2623131T0S2623151T0S2623191T0S2623214T0S2756234T0S2756274T0S275628
- Amount recalled
- 12,292 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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