Reported May 29, 2024 · Ongoing
2008T BlueStar Hemodialysis Machine, Model 191124 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 191124 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
- Number191124
- UDI/DI00840861102082
- Serial Numbers
931 of 931 codes
0T0S2525510T0S2528010T0S2528061T0S2559081T0S2561800T0S2517920T0S2518090T0S2518110T0S2528100T0S2515850T0S2518830T0S2518991T0S2561791T0S2561831T0S2561841T0S2561851T0S2561881T0S2561901T0S2561921T0S2561931T0S2561971T0S2562131T0S2562191T0S2562201T0S2562331T0S2562491T0S2562551T0S2562561T0S2562621T0S2562781T0S2562811T0S2562821T0S2562862T0S2648342T0S2648392T0S2648522T0S2648563T0S2722113T0S2741763T0S2741773T0S2741783T0S2741833T0S2741873T0S2741893T0S2741903T0S2741923T0S2741943T0S2741953T0S2741973T0S2742023T0S2742043T0S2742053T0S2742073T0S2742091T0S2559211T0S2559241T0S2559361T0S2559370T0S2521510T0S252175
- Amount recalled
- 931 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.
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.
Free recall alerts
Get alerted about new Fresenius Medical Care Holdings, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.