Recall of 2008T Hemodialysis Systems with CDX and BlueStar Premium Upgrade Kit due to risk of incomplete disinfection after power failure during cleaning, potentially exposing patients to disinfectant.
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 may not properly disinfect after a power failure during cleaning, risking exposure to disinfectant chemicals in the patient's treatment. This could cause harm to patients using the system.
If a power failure occurs during the cleaning program with the auto-start feature enabled, the machine may start dialysis treatment even though the disinfection process is incomplete. This can leave disinfectant chemicals in the patient's treatment solution, potentially causing harm.
Patients using the recalled hemodialysis systems with the specific BlueStar Premium Upgrade Kit are at risk. Those who have the system with part numbers listed in the recall are most affected.
Check for the 2008T Hemodialysis System with CDX and part number 190713, which requires the 2008T BlueStar Premium Upgrade Kit (part number 191138). The product serial numbers listed in the recall document indicate affected units.
If your machine has the 2008T Hemodialysis System with CDX and part number 190713, it may start dialysis treatment during a power failure, risking incomplete disinfection.
The machine may start dialysis treatment during a power failure, leading to incomplete disinfection and potential exposure to disinfectant chemicals in the patient's treatment.
The affected units have part number 190713 with the 2008T BlueStar Premium Upgrade Kit (part number 191138). The specific serial numbers listed in the recall document indicate affected units.
No, but you should check if your machine has the affected part numbers. The recall requires caution during power failures, not immediate discontinuation.
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-3194-2018 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-3194-2018 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.
