Fresenius 2008T HD SYS W/O CDX BLUESTAR: Potential PCBA Leaching Risk

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Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920, N/A · Waltham, MA 02451-1521

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Medical Care is recalling certain 2008T HD SYS W/O CDX BLUESTAR hemodialysis machines 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.

Why it’s dangerous

The recall is for potential PCBA leaching from the tubing of hemodialysis machines. PCBA (Printed Circuit Board Assembly) components may leach into the dialysis fluid, which could then enter the patient's bloodstream during treatment. This poses a risk of potential health hazards if the leached material is absorbed by the patient.

Who’s affected

Patients using hemodialysis machines with the recalled model numbers and serial numbers listed in the recall notice are affected. Healthcare providers who use these machines for dialysis treatments are at the highest risk.

How to tell if you have this one

Check if your hemodialysis machine has the model number 2008T HD SYS W/O CDX BLUESTAR and the specific serial numbers listed in the recall notice. The serial numbers start with '1T0S', '2T0S', '0T0S', or '8T0S' followed by digits.

Brand
Fresenius
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Machine Details
Verify your hemodialysis machine's model number and serial number against the list provided in the recall notice.

✎ GovInfoNow

Questions people ask

What is the specific model of hemodialysis machine being recalled?

The recalled model is 2008T HD SYS W/O CDX BLUESTAR.

What is the hazard with these machines?

Potential PCBA leaching from the tubing, which could enter the patient's bloodstream during dialysis.

How can I check if my machine is affected?

Check your machine's serial number against the list of affected serial numbers provided in the recall notice.

Take action

Contact Fresenius

We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0034-2024 — Fresenius Fresenius

Hello,

I own a Fresenius that is covered by recall Z-0034-2024 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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Where this comes from

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.

Official source: FDA Recall #Z-0034-2024 (September 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0034-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. W/O CDX BLUESTAR

Recall notice