Fresenius Medical Care recalls 2008K@HOME HEMODIALYSIS SYSTEM Blood Pump Rotor spare part (Model F40015481 Rev A) due to loose/dislodged guide sheaves reported by clinics. Affected units have specific serial numbers and model identifiers.
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 spare blood pump rotor part for their 2008K@HOME hemodialysis system. Clinics have reported that this part can become loose or dislodged after use, which could lead to equipment failure during dialysis treatments.
The blood pump rotor spare part can become loose or dislodged after use in clinics, which may cause equipment failure during hemodialysis treatments. This could lead to interrupted treatment or other complications for patients receiving dialysis.
Healthcare facilities using the 2008K@HOME hemodialysis system with the specific blood pump rotor spare part (Model F40015481 Rev A) are likely affected. Clinicians and dialysis staff are at the highest risk due to potential equipment failure during critical treatments.
Check if your 2008K@HOME hemodialysis system has the blood pump rotor spare part with model number F40015481 Rev A. Affected units have a specific serial number (1K0S172181) and UDI/DI code (00840861100941).
Inspect the blood pump rotor spare part for looseness or dislodgement after use in your hemodialysis system.
Clinics have reported loose or dislodged guide sheaves on this blood pump rotor spare part after use, which could cause equipment failure during hemodialysis treatments.
Check for model number F40015481 Rev A on the blood pump rotor spare part. Affected units have serial number 1K0S172181 and UDI/DI code 00840861100941.
Inspect the part for looseness or dislodgement after use. If loose, contact Fresenius Medical Care for further 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-2345-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2345-2024 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.
