Fresenius Medical Care, North America recalls Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx
Fresenius Medical Care recalls 1.5% dextrose peritoneal dialysis solution due to label mix-up with 4.25% dextrose bags. Affected units contain 2 x 6L bags in a case with NDC 49230-206-60. No remedy specified in recall notice.
Recall notice
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Contact the company & request your remedy
What happened, in plain English
Fresenius Medical Care is recalling 1.5% dextrose peritoneal dialysis solution that may contain 4.25% dextrose bags due to a label mix-up. This mix-up could lead to incorrect dosing and potential health risks for patients using the solution. Read more at govinfonow.com/recall/36211-fresenius-delflex-peritoneal-dialysis-solution-1-5-dextrose-recall-label.
Source Summary by GovInfoNow · govinfonow.com/recall/36211-fresenius-delflex-peritoneal-dialysis-solution-1-5-dextrose-recall-label · Updated October 4, 2026 · FDA enforcement record: FDA #D-0389-2021
Cite this page
“Fresenius Delflex Peritoneal Dialysis Solution 1.5% Dextrose Recall: Label Mix-Up Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36211-fresenius-delflex-peritoneal-dialysis-solution-1-5-dextrose-recall-label. Based on FDA recall #D-0389-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0389-2021%22&limit=1).
Why it’s dangerous
The recall involves a label mix-up where 4.25% dextrose bags were found inside a 1.5% dextrose box. Using the wrong concentration could cause incorrect dosing, potentially leading to health complications for patients on peritoneal dialysis.
Who’s affected
Patients using Fresenius Delflex Peritoneal Dialysis Solution with 1.5% dextrose (NDC 49230-206-60) are affected. Those with the specific lot number 20SU03019 are at highest risk.
How to tell if you have this one
Check for the product name 'Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC' in a case containing 2 x 6 Liter bags. The lot number 20SU03019 and expiration date 6/2022 are specific identifiers for affected units.
- Brand
Fresenius Medical Care- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number 20SU03019 and expiration date 6/2022 on the packaging.
Questions people ask
Is there a remedy for this recall?
The recall notice does not specify any remedy.
What is the specific issue with this product?
A label mix-up occurred where 4.25% dextrose bags were found inside a 1.5% dextrose box.
How can I tell if I have the affected product?
Check for the lot number 20SU03019 and expiration date 6/2022 on the packaging of Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC.
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-0389-2021 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall D-0389-2021 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-0389-2021 (April 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0389-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.