Fresenius Medical Care recalls DELFLEX peritoneal dialysis solution with attached exchange set due to potential leaks from bag perforations. Affected lots 25CU02007-02009.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Fresenius Medical Care is recalling DELFLEX peritoneal dialysis solution with attached exchange sets because bags may have perforations that cause leaks. This could lead to infection risks for patients using the solution.
The solution bags may develop small holes that allow fluid to leak. This could increase the risk of infection for patients who use the solution directly into their abdomen.
Patients using peritoneal dialysis with this specific solution are affected. Those with the lot numbers 25CU02007 through 25CU02009 are most at risk.
Check for the lot numbers 25CU02007, 25CU02008, or 25CU02009 on the packaging. The product is labeled as DELFLEX, 1.5% Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set.
Look for lot numbers 25CU02007, 25CU02008, or 25CU02009 on the packaging.
The product is not safe for use as recalled. Bags may have perforations that cause leaks, increasing infection risk.
Check the lot number on your packaging. If it matches 25CU02007-02009, stop using it and contact Fresenius Medical Care for instructions.
The recall notice does not specify replacement options. Contact Fresenius Medical Care directly for assistance.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall D-0512-2026 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall D-0512-2026 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.