Fresenius Medical Care recalls 2008T Hemodialysis Systems with BlueStar Premium Upgrade Kit due to risk of disinfectant not fully removed during power failures, potentially contaminating patient dialysate.
In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.
Fresenius Medical Care is recalling certain 2008T hemodialysis systems that come with the BlueStar Premium Upgrade Kit. If a power failure occurs during cleaning, the machine may start dialysis without completing a mandatory rinse, risking disinfectant contamination in the patient's treatment.
During cleaning/disinfection programs, if a power failure happens while the auto-start feature is enabled, the machine may begin dialysis without completing a mandatory rinse. This can leave disinfectant chemicals in the dialysate that the patient receives, potentially causing health issues.
Patients using the recalled 2008T Hemodialysis System with BlueStar Premium Upgrade Kit are most at risk. This affects individuals with kidney failure who rely on dialysis treatments.
Check for the part number 190766 on the 2008T Hemodialysis System. The recall applies only to units sold with the BlueStar Premium Upgrade Kit (part number 191138).
If your machine has the BlueStar Premium Upgrade Kit (part number 191138), it may start dialysis during a power failure without completing a mandatory rinse.
Reach out to Fresenius Medical Care for guidance on safe use or potential remedies.
The machine may start dialysis without completing a mandatory rinse during a power failure, risking disinfectant contamination in the patient's treatment.
The 2008T Hemodialysis System with part number 190766, when used with the BlueStar Premium Upgrade Kit (part number 191138).
The recall does not specify a fix; users should contact Fresenius Medical Care 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-3195-2018 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-3195-2018 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.
