Fresenius Medical recalls 2008T Hemodialysis Systems with Bibag due to potential PCBA leaching from tubing. Affected units have specific serial numbers listed in the recall notice.
Potential PCBA leaching from tubing of hemodialysis machines.
Fresenius Medical is recalling certain 2008T Hemodialysis Systems with Bibag models because of a potential risk of PCBA leaching from the tubing. This could pose a health hazard if the leached material enters the patient's bloodstream during dialysis.
The tubing in these hemodialysis machines may leach PCBA (printed circuit board assembly) materials. If these materials enter the patient's bloodstream during dialysis, they could cause health issues.
Patients using hemodialysis machines with the recalled 2008T model and Bibag components are most at risk. The recall affects specific serial numbers listed in the official notice.
Check if your hemodialysis machine has the model number 190766 and the listed serial numbers (e.g., 1T0S261032, 1T0S261004, etc.).
Compare your machine's serial number with the list of affected serial numbers provided in the recall notice.
The recall is due to potential PCBA leaching from tubing, which could pose a health risk if the material enters the patient's bloodstream during dialysis. However, the risk level is considered low.
Check if your machine has the model number 190766 and a serial number listed in the provided recall notice (e.g., 1T0S261032, 1T0S261004, etc.).
The recall does not specify a remedy, so contact Fresenius Medical directly for guidance on next steps.
We’ve drafted a message you can send Fresenius Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0030-2024 — Fresenius Medical Fresenius Medical Hello, I own a Fresenius Medical that is covered by recall Z-0030-2024 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.
