Fresenius Medical Care recalls Dialyzer Optiflux 160NRe dialyzers with potential internal blood leaks due to cracked polyurethane. Affected units have specific UDI numbers and expire June 30, 2027.
Potential for internal blood leaks due to cracked polyurethane
Fresenius Medical Care is recalling Dialyzer Optiflux 160NRe dialyzers that may have cracked polyurethane, causing internal blood leaks. This could lead to serious health risks if the device is used without repair.
The dialyzer's polyurethane component can crack over time, potentially allowing blood to leak internally. This could cause serious health complications during hemodialysis treatments if not addressed.
Patients using hemodialysis treatments with this specific dialyzer model are most at risk. Healthcare providers who use the device in clinical settings may also be affected.
Check for UDI numbers starting with 24HU06011-00840861100149-270630 or 24HU06010-00840861100149-270630. The dialyzers expire on June 30, 2027.
Look for UDI numbers starting with 24HU06011-00840861100149-270630 or 24HU06010-00840861100149-270630 on the dialyzer packaging.
The recall is due to potential internal blood leaks caused by cracks in the polyurethane component.
Check for UDI numbers starting with 24HU06011-00840861100149-270630 or 24HU06010-00840861100149-270630. The dialyzers expire on June 30, 2027.
The recall record does not specify a remedy, so contact Fresenius Medical Care for guidance.
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-0801-2025 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0801-2025 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.
