Fresenius Medical Care recalls Optiflux F160NR dialyzers with specific lot numbers due to potential external blood leaks. Affected units may require replacement.
Potential for external blood leaks from the dialyzer header
Fresenius Medical Care is recalling certain Optiflux F160NR dialyzers that could leak blood externally. This hazard poses a risk to patients using hemodialysis treatments.
The dialyzer header may leak blood outside the treatment system during use. This could expose patients to bloodborne pathogens or cause other complications during dialysis.
Patients receiving hemodialysis treatments using the recalled dialyzers are most at risk. Healthcare providers who use these units should also check their inventory.
Check for lot numbers 18HU06016, 18HU06017, 18HU06018, or 18HU06019 on the dialyzer packaging. The product code is 0500316E.
Look for lot numbers 18HU06016, 18HU06017, 18HU06018, or 18HU06019 on the dialyzer packaging.
The product code is 0500316E.
Lot numbers 18HU06016, 18HU06017, 18HU06018, and 18HU06019 are affected.
The recall record does not specify a remedy.
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-0658-2019 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0658-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
