Recall of 2008T BlueStar Hemodialysis Machine Model 191128 with Blood Pump Rotor Model F40015481 Rev A due to loose guide sheaves after use. Affected units have specific serial numbers.
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 is recalling certain 2008T BlueStar hemodialysis machines with a specific blood pump rotor model because clinics reported loose guide sheaves after use. This could lead to equipment malfunction during dialysis treatments.
The blood pump rotor (model F40015481 Rev A) can become loose or dislodged after use, which may cause equipment malfunction during dialysis treatments. This could potentially lead to treatment interruptions or other complications.
Healthcare facilities using the recalled hemodialysis machines are most at risk. Patients receiving dialysis treatments with these machines may be affected if the pump rotor becomes loose.
Check if your hemodialysis machine has the model number 191128 and the blood pump rotor model F40015481 Rev A. Affected units have specific serial numbers listed in the recall notice.
Identify your hemodialysis machine's model number (191128) and blood pump rotor model (F40015481 Rev A) to see if it's affected.
Reach out to Fresenius Medical for guidance on next steps if your machine is affected.
The recall is due to reports of loose guide sheaves in the blood pump rotor after use, which could cause equipment malfunction during dialysis treatments. However, the hazard is not immediately dangerous in normal use.
Check if your hemodialysis machine has model number 191128 and blood pump rotor model F40015481 Rev A. Affected units have specific serial numbers listed in the recall notice.
Contact Fresenius Medical for guidance on next steps if your machine is affected.
We’ve drafted a message you can send Fresenius Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1869-2024 — Fresenius Medical Fresenius Medical Hello, I own a Fresenius Medical that is covered by recall Z-1869-2024 from Fresenius Medical. 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.
