Recall of 2008T BlueStar Hemodialysis Machines (Model 191124) with Blood Pump Rotor (P/N F40015481 Rev A) due to loose guide sheaves reported by clinics. Affected units have specific serial numbers listed.
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 certain 2008T BlueStar hemodialysis machines with a specific blood pump rotor model due to reports of loose guide sheaves. This could lead to equipment malfunction during dialysis treatments.
The blood pump rotor (model F40015481 Rev A) has been reported to become loose or dislodged after some use in clinics. This could cause the machine to malfunction during dialysis treatments, potentially affecting patient safety.
Healthcare facilities that own or use the recalled hemodialysis machines are most at risk. Patients using these machines during dialysis treatments may face equipment malfunctions.
Check if your hemodialysis machine has the model number 191124 and the blood pump rotor model F40015481 Rev A. Affected units have specific serial numbers listed in the recall notice.
Verify if your hemodialysis machine has the model number 191124 and the blood pump rotor model F40015481 Rev A.
Reach out to Fresenius Medical Care for guidance on next steps if your machine is affected.
This recall applies to clinical hemodialysis machines used in healthcare facilities, not home dialysis equipment.
Check for the model number 191124 and blood pump rotor model F40015481 Rev A. Affected units have specific serial numbers listed in the recall notice.
No, but you should contact Fresenius Medical Care if your machine is affected to get 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-1867-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-1867-2024 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.