Recall of Fresenius 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. Affected units have specific serial numbers. Consumers should check their device and contact Fresenius for guidance.
Potential PCBA leaching from tubing of hemodialysis machines.
Fresenius is recalling certain 2008T Hemodialysis Systems without CDX because of a potential risk of PCBA leaching from the tubing. This could pose a health hazard if the leached material enters the patient's bloodstream during dialysis. Affected units have specific serial numbers listed in the recall notice.
The tubing in these hemodialysis machines may leach PCBA (printed circuit board assembly) materials. If these materials enter the patient's bloodstream during dialysis, they could cause health issues. The risk is not immediate but depends on the machine's use and the patient's condition.
Patients using hemodialysis machines with the recalled 2008T model without CDX are most at risk. The recall affects specific serial numbers listed in the official notice.
Check if your hemodialysis machine has the model number 2008T without CDX and the serial numbers listed in the recall notice. The serial numbers are provided in the official recall list.
Verify if your hemodialysis machine has the model number 2008T without CDX and one of the listed serial numbers.
Reach out to Fresenius Medical Care Holdings, Inc. for further guidance on the recall and next steps.
The recalled model is the 2008T Hemodialysis System without CDX.
Check if your machine has the model number 2008T without CDX and one of the specific serial numbers listed in the recall notice.
Contact Fresenius Medical Care Holdings, Inc. for guidance on the 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-0029-2024 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-0029-2024 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.
