Fresenius Medical Care recalls 2008K@HOME HEMODIALYSIS SYSTEM Blood Pump Rotor spare part (Model F40015481 Rev A) due to reported loose/dislodged guide sheaves in clinics after use. 190828 units affected.
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.
Fresenius Medical Care is recalling a specific spare part for their 2008K@HOME hemodialysis system. Clinics have reported loose or dislodged guide sheaves after using this part, which could lead to equipment failure during dialysis treatments.
The spare part (Blood Pump Rotor) has been reported to become loose or dislodged in clinics after use. This could cause equipment failure during dialysis treatments, potentially leading to treatment interruptions or complications for patients.
Healthcare facilities using the 2008K@HOME hemodialysis system with the specific spare part model F40015481 Rev A are most at risk. Patients receiving dialysis through this system could be affected if the spare part fails.
Check for the model number F40015481 Rev A on the spare part. Affected units have serial numbers listed in the recall notice (e.g., 2K0S179489, 3K0S184885).
Verify the model number on the spare part is F40015481 Rev A and check the serial number against the list provided in the recall notice.
Yes, this spare part is for the 2008K@HOME hemodialysis system, which is used in home dialysis treatments.
Check the model number on the spare part (F40015481 Rev A) and compare the serial number to the list of affected units provided in the recall notice.
The recall notice does not specify a remedy, so you should check with Fresenius Medical Care directly for guidance on next steps.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-2341-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2341-2024 from Fresenius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
