Fresenius Medical Care recalls 5008X Blood Tubing Sets with potential online port errors when connecting SafeLine to substitution fluid port. Affected units include specific model numbers and lots manufactured after February 26, 2026.
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Fresenius Medical Care is recalling 5008X Blood Tubing Sets that may cause online port errors when connecting the SafeLine to the substitution fluid port. This could lead to incorrect blood flow measurements during dialysis treatments. Affected units have specific model numbers and were manufactured after February 26, 2026.
The connection between the SafeLine of the 5008X CAREset and the substitution fluid port of the 5008X CAREsystem can cause online port errors. This may lead to incorrect blood flow measurements during dialysis, potentially affecting treatment accuracy.
Patients using dialysis machines with the recalled 5008X Blood Tubing Sets are most at risk. Healthcare providers who use these sets for dialysis treatments may also be affected.
Check for model numbers 03-5110-6, 03-5300-3, 03-5300-3C, or 03-5350-8 on the tubing set. Units manufactured after February 26, 2026 are affected. The lot numbers listed in the recall notice are also specific to affected units.
Identify the model number on the tubing set to determine if it is affected (03-5110-6, 03-5300-3, 03-5300-3C, or 03-5350-8).
Ensure the tubing set was manufactured after February 26, 2026 to confirm it is part of the recall.
Model numbers 03-5110-6, 03-5300-3, 03-5300-3C, and 03-5350-8 are affected.
Units manufactured after February 26, 2026 are affected.
Check the model number on the tubing set and verify it was manufactured after February 26, 2026.
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-2702-2026 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2702-2026 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.
