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Drug recall · FDA · Published June 18, 2024

Fresenius Medical Care Holdings, Inc. recalls DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange

Fresenius Medical Care recalls DELFLEX peritoneal dialysis solution with slow leaks due to tube weld failure. Learn about affected products and safety steps.

🇺🇸 FDA recall #D-0608-2024DrugFresenius Medical Care ›
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Contact the company & request your remedy

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Medical Care is recalling peritoneal dialysis solution that can leak slowly over time due to tube weld failures. This risk could lead to infections or other complications if not detected early. Read more at govinfonow.com/recall/32628-fresenius-delflex-peritoneal-dialysis-solution-recall-slow-leak-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32628-fresenius-delflex-peritoneal-dialysis-solution-recall-slow-leak-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0608-2024

Cite this page

“Fresenius DELFLEX Peritoneal Dialysis Solution Recall: Slow Leak Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32628-fresenius-delflex-peritoneal-dialysis-solution-recall-slow-leak-risk. Based on FDA recall #D-0608-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0608-2024%22&limit=1).

Why it’s dangerous

The solution's tube welds can fail, causing slow leaks that are hard to detect. If undetected, leaks may lead to infections or other complications in patients needing peritoneal dialysis.

Who’s affected

People using peritoneal dialysis treatment with this specific solution are affected. Those with compromised immune systems or existing infections are at higher risk.

How to tell if you have this one

Check for the product name 'DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE' and the expiration date 07/31/2025. The product comes in a single-dose container with a specific NDC code.

  • Brand
    Fresenius Medical Care
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check for Leaks

    Inspect the solution container for slow leaks, which may be difficult to detect but could indicate tube weld failure.

  2. Contact Manufacturer

    Call Fresenius Medical Care at 1-800-323-5188 for assistance with the recall.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product has a risk of slow leaks due to tube weld failure, so it should not be used until the recall is addressed.

How do I know if I have the recalled product?

Check for the product name 'DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE' and the expiration date 07/31/2025.

What should I do if I have the recalled product?

Inspect for slow leaks and contact Fresenius Medical Care at 1-800-323-5188 for guidance.

Take action

Contact Fresenius Medical Care

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-0608-2024 — Fresenius Medical Care Fresenius Medical Care

Hello,

I own a Fresenius Medical Care that is covered by recall D-0608-2024 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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Where this comes from

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.

  • Official source: FDA Recall #D-0608-2024 (June 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0608-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA