Fresenius Medical Care Renal Therapies Group, LLC recalls DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2
Fresenius Medical Care recalls DELFLEX Peritoneal Dialysis Solution due to leakage risk. This affects specific 3L and 2L bags with certain lot numbers. Patients should contact the manufacturer for guidance.
Stop using this now
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
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What happened, in plain English
Fresenius Medical Care is recalling specific batches of DELFLEX Peritoneal Dialysis Solution because they may leak, which could lead to infection. This is serious for people using peritoneal dialysis who rely on the solution. Read more at govinfonow.com/recall/41007-fresenius-medical-care-delflex-peritoneal-dialysis-solution-recall-leakage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41007-fresenius-medical-care-delflex-peritoneal-dialysis-solution-recall-leakage-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0604-2018
Cite this page
“Fresenius Medical Care DELFLEX Peritoneal Dialysis Solution Recall: Leakage Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41007-fresenius-medical-care-delflex-peritoneal-dialysis-solution-recall-leakage-risk. Based on FDA recall #D-0604-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0604-2018%22&limit=1).
Why it’s dangerous
The solution bags may leak, which can cause contamination of the peritoneal cavity. This increases the risk of infection, a serious complication for patients on peritoneal dialysis.
Who’s affected
People using peritoneal dialysis with the recalled DELFLEX solution bags are affected. Those with the specific lot numbers and packaging details listed in the recall are most at risk.
How to tell if you have this one
Check for the 3L bags (4-pack, NDC 49230-209-30) or 2L bags (6-pack, NDC 49230-209-23) with lot numbers 17KU03004-03007. These were manufactured with an expiration date of 08/2019.
- Brand
Fresenius Medical Care- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled DELFLEX Peritoneal Dialysis Solution bags with the specified lot numbers and packaging details.
Questions people ask
What is the specific product being recalled?
The recalled product is DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, in 3L (4-pack, NDC 49230-209-30) or 2L (6-pack, NDC 49230-209-23) packages.
What lot numbers are affected?
Lot numbers 17KU03004, 17KU03005, 17KU03006, and 17KU03007 are affected.
How can I check if my product is recalled?
Check the lot number on the packaging. The recalled items have specific lot numbers (17KU03004-03007) and packaging details listed in the recall notice.
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-0604-2018 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall D-0604-2018 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-0604-2018 (December 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0604-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.