CLASS II ONGOING Device recall · Reported 17 Jul 2024 · FDA Enforcement Report
RTL190828: 2008K@Home Hemodialysis System recalled
Fresenius Medical Care Holdings is recalling RTL190828: 2008K@Home Hemodialysis System - Blood Pump Rotor spare part, distributed nationwide in the US. The recall was initiated on 3 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2345-2024
- FDA event ID
- 94775
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jun 2024
- FDA classified
- 11 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Jun 2024 | Recall initiated by company | |
| 11 Jul 2024 | Classified by FDA | +38 days |
| 17 Jul 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Where it was distributed
Domestic: Nationwide Distribution. International: Canada.
Questions about this recall
Why was it 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.
Which lots are affected?
Model Number: RTL190828 (Rental Units); UDI/DI: 00840861100941; Serial Number: 1K0S172181
Where was it sold?
Domestic: Nationwide Distribution. International: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 94775This product is part of a recall event; the main page for the event is RTL190395: 2008K@Home Machine, Short Cab,Olc/DP,HP recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | RTL190395: 2008K@Home Machine, Short Cab,Olc/DP,HP recalled | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS II | RTLR190395: 2008K@Home Machine, Short Cab,Olc/DP,HP recalled | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS II | 190904 2008K@Home Hemodialysis System W/ Bibag recalled | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS II | 190395: 2008K@Home Machine, Short Cab,Olc/DP,HP recalled | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS II | 190828: 2008K@Home Hemodialysis System - Blood Pump Rotor spare part recalled | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS II | RTL190904: 2008K@Home Hemodialysis System W/ Bibag recalled | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS II | 191014: 2008K@Home HD System W/Bibag (Canada) recalled | Fresenius Medical Care Holdings | Other | Nationwide |
More recalls from Fresenius Medical Care Holdings
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5008X Blood Tubing Set recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide |
| Device | CLASS II | Bicarby" Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Packaging Defects | Nationwide |
| Device | CLASS II | Bicarby Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | TX |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |