Fresenius Medical Care recalls 2008T HD SYS CDX BLUESTAR hemodialysis machines due to potential PCBA leaching from tubing. Affected units have specific serial numbers; contact for details.
Potential PCBA leaching from tubing of hemodialysis machines.
Fresenius Medical Care is recalling certain 2008T HD SYS CDX BLUESTAR hemodialysis machines because of a potential risk of PCBA leaching from the tubing. This could pose a hazard to users, though the exact risk level isn't specified in the recall notice.
The recall states that PCBA (printed circuit board assembly) components may leach from the tubing of these hemodialysis machines. However, the recall does not specify how this leaching could cause harm or what the actual risk level is.
Hemodialysis patients and healthcare providers using the affected 2008T HD SYS CDX BLUESTAR machines. Those most at risk are individuals with specific serial numbers listed in the recall.
Check if your machine has the model number 191124 and the listed serial numbers (e.g., 1T0S261032, 1T0S261004, etc.). The recall includes specific serial numbers provided in the record.
Verify your machine's serial number against the list of affected units provided in the recall notice.
The recall states there is a potential for PCBA leaching from the tubing, but it does not specify how this could cause harm or the exact risk level.
Check your machine's serial number against the list of affected units provided in the recall notice, which includes specific serial numbers like 1T0S261032 and 1T0S261004.
The recall does not specify a remedy, so contact Fresenius Medical Care for further instructions.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-0032-2024 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0032-2024 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.
