Recall of 2008K@HOME HEMODIALYSIS SYSTEM with Blood Pump Rotor spare part (Model F40015481 Rev A) due to loose/dislodged guide sheaves reported by clinics.
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 that this part can become loose or dislodged after use, which may cause mechanical failure during dialysis treatment.
The Blood Pump Rotor spare part (Model F40015481 Rev A) has been reported to become loose or dislodged after use by clinics. This could lead to mechanical failure during dialysis treatments, potentially causing treatment interruptions or equipment damage.
Healthcare facilities using the 2008K@HOME hemodialysis system with the specific spare part (Model F40015481 Rev A) are affected. Patients receiving dialysis through this system are at risk if the spare part becomes loose or dislodged.
Check if your 2008K@HOME hemodialysis system includes the Blood Pump Rotor spare part with Model Number F40015481 Rev A. The serial numbers listed in the recall notice are also part of this affected batch.
Inspect the Blood Pump Rotor spare part for signs of looseness or dislodgement.
Yes, this is a spare part for the 2008K@HOME hemodialysis system used in blood purification treatments.
The spare part has Model Number F40015481 Rev A and the serial numbers listed in the recall notice.
No, but clinics should check the spare part for looseness or dislodgement before use.
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-2340-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2340-2024 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.
