Recall of 2008T HD SYS hemodialysis machines with potential PCBA leaching from tubing. Affected units have specific serial numbers and model numbers. No remedy provided in official notice.
Potential PCBA leaching from tubing of hemodialysis machines.
Fresenius Medical Care recalls certain hemodialysis machines (2008T HD SYS W/O CDX W/BIBAG BLUESTAR) due to potential PCBA leaching from tubing. This could pose a risk of harmful substances entering the patient's bloodstream during dialysis treatment.
The recall states there is a potential for PCBA (printed circuit board assembly) materials to leach from the tubing of these hemodialysis machines. This could introduce harmful substances into the patient's bloodstream during dialysis treatment, though the exact risk level is not specified in the recall notice.
Patients using hemodialysis machines with the specific serial numbers listed in the recall. Healthcare providers who operate these machines are most at risk.
Check if your hemodialysis machine has the model number 191130 and the listed serial numbers (e.g., 1T0S261032, 1T0S260995, etc.). The recall covers specific units sold with the 2008T HD SYS W/O CDX W/BIBAG BLUESTAR configuration.
Verify your hemodialysis machine's model number (191130) and serial number against the list provided in the recall notice.
The recall states there is a potential for PCBA materials to leach from the tubing of these hemodialysis machines, which could introduce harmful substances into the patient's bloodstream during dialysis treatment.
The official recall notice does not provide a remedy; you should check your machine's serial number against the list provided to determine if it is affected.
The recall does not specify the risk level or potential for serious injury; it only mentions potential PCBA leaching.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0035-2024 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0035-2024 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.
