Fresenius recalls 2008T GEN 2 Bibag hemodialysis machines with potential PCBA leaching from tubing. Affected units have specific serial numbers. Contact for details.
Potential PCBA leaching from tubing of hemodialysis machines.
Fresenius is recalling certain 2008T GEN 2 Bibag hemodialysis machines due to potential PCBA leaching from tubing. This could pose a risk to users during dialysis treatments.
PCBA (printed circuit board assembly) components may leach from the tubing in these machines during normal use. This could potentially contaminate the dialysis fluid and pose a health risk to patients.
Hemodialysis patients and healthcare providers using the affected machines. Those with the specific serial numbers listed in the recall are most at risk.
Check if your machine has the model number 190895 and the listed serial numbers (e.g., 1T0S261032, 1T0S260995, etc.). The recall covers specific units sold between 2008 and 2010.
Look for the serial number on your machine's label. If it matches the list of affected serial numbers provided in the recall, it is part of the recall.
Reach out to Fresenius Medical Care Holdings, Inc. directly for instructions on how to safely handle the affected machine.
The affected machines have model number 190895.
Check if your machine's serial number matches the list of affected serial numbers provided in the recall notice.
No, but you should check if your machine is affected and contact Fresenius for guidance on next steps.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0031-2024 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0031-2024 from Fresenius. 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.
