Recall of 2008T HD SYS CDX W/BIBAG BLUESTAR hemodialysis machines due to potential PCBA leaching from tubing. Affected units have specific serial numbers listed. No remedy provided in official notice.
Potential PCBA leaching from tubing of hemodialysis machines.
Fresenius Medical Care is recalling certain hemodialysis machines (2008T HD SYS CDX W/BIBAG BLUESTAR) because tubing may leach PCBA components. This could pose a risk to users if the leached materials enter the bloodstream during dialysis.
PCBA (printed circuit board assembly) components may leach from the tubing into the dialysis fluid. If these materials enter the patient's bloodstream during treatment, they could cause health issues.
Hemodialysis patients using the affected machines are most at risk. The recall applies to specific serial numbers listed in the official notice.
Check if your machine has the model '2008T HD SYS CDX W/BIBAG BLUESTAR' and one of the listed serial numbers (e.g., 1T0S261032, 1T0S260995, etc.).
Identify your machine's model and serial number to confirm if it's affected.
The recall is due to potential PCBA leaching from the tubing of these hemodialysis machines.
The official notice does not provide a remedy; no action is required beyond checking if your machine is affected.
Check if your machine has the model '2008T HD SYS CDX W/BIBAG BLUESTAR' and one of the specific serial numbers listed in the recall notice.
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-0033-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0033-2024 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.
