Reported May 29, 2024 · Ongoing
2008T BlueStar Hemodialysis Machine, Model 191128 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 191128 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
- Number191128
- UDI/DI00840861102105
- Serial Numbers
334 of 334 codes
3T0S2742101T0S2601831T0S2604551T0S2604561T0S2604851T0S2602731T0S2602831T0S2604901T0S2601581T0S2601821T0S2602663T0S2690113T0S2732233T0S2742163T0S2742253T0S2746783T0S2746801T0S2602812T0S2680082T0S2680162T0S2647752T0S2680092T0S2680132T0S2680142T0S2680153T0S2690213T0S2690263T0S2742153T0S2742223T0S2742313T0S2742341T0S2601541T0S2604811T0S2605431T0S2605501T0S2605523T0S2742133T0S2742301T0S2602421T0S2602501T0S2605101T0S2605142T0S2679012T0S2679052T0S2679062T0S2679111T0S2605411T0S2605462T0S2647803T0S2742333T0S2746853T0S2746913T0S2746971T0S2601591T0S2601641T0S2601721T0S2602121T0S2602161T0S2602211T0S260269
- Amount recalled
- 334 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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