Recall of 5008X HDF Hemodialysis Blood Tubing Sets with potential blood leaks during hemodialysis procedures. Affected models include 03-5100-7 and variants. Contact manufacturer for details.
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Fresenius Medical Care is recalling 5008X HDF Hemodialysis Blood Tubing Sets that may cause blood leaks between the tubing and venous chamber during dialysis. This could lead to serious complications if the leak occurs during treatment.
The tubing set may allow blood to leak between the lower port of the venous chamber and the tubing during hemodialysis procedures. This leak could cause blood to enter the dialysis circuit, potentially leading to serious complications if not detected and addressed promptly.
Patients receiving hemodialysis treatments using the recalled tubing sets are most at risk. Healthcare providers who use these sets for dialysis procedures may also be affected.
Check for model numbers 03-5100-7, 03-5100-7C, or 03-5150-2 on the tubing set. The lot numbers 24LR01214, 24SR01010, 25ER01800 or similar variants are also indicators of affected units.
Identify the model number on the tubing set, which may be 03-5100-7, 03-5100-7C, or 03-5150-2.
Reach out to Fresenius Medical Care for specific instructions on how to address the issue with the recalled tubing sets.
The affected models are 5008X Standard HDF Bloodline with model numbers 03-5100-7, 03-5100-7C, and 03-5150-2.
Check for model numbers 03-5100-7, 03-5100-7C, or 03-5150-2 on the tubing set, and lot numbers such as 24LR01214, 24SR01010, or 25ER01800.
Contact Fresenius Medical Care for specific instructions on how to address the issue with the recalled tubing sets.
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-1992-2025 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-1992-2025 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.
