Fresenius Medical Care recalls 2008K@HOME HD System blood pump rotor spare part (model F40015481 Rev A) due to loose guide sheaves reported by clinics. Affected units have specific serial numbers in Canada.
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 blood pump rotor spare part for the 2008K@HOME HD System in Canada. Clinics reported loose or dislodged guide sheaves after use, which could lead to equipment malfunction.
The blood pump rotor spare part has been reported to become loose or dislodged after use by clinics. This could cause the equipment to malfunction, potentially affecting patient safety during blood treatment.
Healthcare facilities in Canada using the 2008K@HOME HD System with the specific blood pump rotor spare part (model F40015481 Rev A) are affected. Staff handling the equipment are at risk if the guide sheaves become loose.
Check if your 2008K@HOME HD System has the blood pump rotor spare part with model number F40015481 Rev A and the listed serial numbers in Canada.
Inspect the blood pump rotor spare part for loose or dislodged guide sheaves. If found, stop using the system until it is repaired.
Clinics reported an increased number of complaints about loose or dislodged guide sheaves on this blood pump rotor spare part after use.
The affected units are the 2008K@HOME HD System with blood pump rotor spare part model F40015481 Rev A in Canada, with specific serial numbers listed in the recall notice.
Inspect the part for loose or dislodged guide sheaves. If found, stop using the system until it is repaired. The recall does not specify a return or replacement deadline.
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-2342-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2342-2024 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.
