Fresenius Medical Care recalls 2008K@HOME HEMODIALYSIS SYSTEM spare parts with loose guide sheaves. Affected units have model F40015481 Rev A and serial numbers starting with 5K0S.
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 spare blood pump rotors for their 2008K@HOME hemodialysis systems. Clinics reported loose guide sheaves after use, which could lead to mechanical failure during dialysis treatments.
Loose guide sheaves in the blood pump rotor can cause mechanical failure during dialysis. This may lead to equipment malfunction or potential injury to patients if the rotor dislodges during treatment.
Healthcare facilities using the 2008K@HOME hemodialysis system with the specific rotor model (F40015481 Rev A) are affected. Clinicians and patients using these systems are at risk of mechanical failure.
Check for model number F40015481 Rev A on the rotor. Affected units have serial numbers starting with 5K0S and were sold with the 2008K@HOME hemodialysis system.
Verify the rotor model number is F40015481 Rev A to confirm if it's affected.
Reach out to Fresenius Medical Care for guidance on next steps if the rotor is affected.
Clinics reported loose/dislodged guide sheaves after use, which could cause mechanical failure during dialysis treatments.
The affected rotor model is F40015481 Rev A with serial numbers starting with 5K0S.
No, but affected units should be checked for loose guide sheaves and contacted for guidance.
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-2346-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2346-2024 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.
