Fresenius Medical Care recalls DELFLEX peritoneal dialysis solution with possible bag leaks due to perforations. Affected lots: 25CU02002, 25CU02011, 25CU02012, 25CU02013. Stop using immediately if you have this product.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Fresenius Medical Care is recalling DELFLEX peritoneal dialysis solution because it may have perforations in the bags that could cause leaks. This poses a risk of infection or other complications during dialysis treatment. If you have the recalled product, stop using it immediately and contact Fresenius for instructions.
The solution bags may have small holes that allow fluid to leak out. This could lead to infections or other complications during dialysis, as the leaked fluid might enter the abdominal cavity.
People using peritoneal dialysis treatment with the recalled DELFLEX solution are affected. Those with the specific lot numbers listed in the recall are at highest risk.
Check the lot numbers on the product: 25CU02002, 25CU02011, 25CU02012, or 25CU02013. The product is labeled as DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only.
If you have the recalled product, stop using it right away to prevent potential leaks and infections.
The recalled product is DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, lot numbers 25CU02002, 25CU02011, 25CU02012, or 25CU02013.
The solution bags may have perforations that cause leaks, which could lead to infections or other complications during dialysis treatment.
Stop using it immediately and contact Fresenius Medical Care for instructions on how to return or dispose of it safely.
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-0513-2026 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall D-0513-2026 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.