Recall of 2008T Hemodialysis SYS with CDX models due to potential PCBA leaching from tubing. Affected units have specific serial numbers; contact manufacturer for details.
Potential PCBA leaching from tubing of hemodialysis machines.
Fresenius Medical Care is recalling certain 2008T Hemodialysis SYS machines with CDX that may leach PCBA from tubing. This could pose a risk to users through potential contamination of dialysis solutions.
PCBA (printed circuit board assembly) components in the tubing may leach into the dialysis solution. This could potentially contaminate the treatment fluid, though the risk is not described as causing serious injury in normal use.
Patients using hemodialysis machines with the recalled serial numbers are most at risk. Healthcare providers who own or use these machines should check their units.
Check if your machine has the model number 190713 and serial numbers listed in the recall notice. The affected units have specific serial numbers starting with 1T0S, 2T0S, or 0T0S.
Verify your machine's serial number against the list of affected units provided in the recall notice.
The recall states potential PCBA leaching from tubing, but does not specify that it causes serious injury in normal use. The risk is described as low.
Check if your machine has the model number 190713 and a serial number listed in the provided recall notice.
The recall does not specify a remedy, so contact Fresenius Medical Care directly for further instructions.
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-0028-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0028-2024 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.
