Stop using nowDrug recall · FDA · Published December 28, 2023
Fresenius Recalls DELFLEX Dialysis Solution Due to Sterility Risk
Fresenius Medical Care recalls specific lots of DELFLEX Peritoneal Dialysis Solution due to a lack of sterility assurance. Check your lot number immediately.
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Peritoneal Dialysis Solution in Biofine containers containing 1.5% Dextrose. The recall affects 6000mL bags distributed nationwide due to a lack of sterility assurance. This means the product may not be free from harmful microorganisms. Read more at govinfonow.com/recall/32908-fresenius-recalls-delflex-dialysis-solution-due-to-sterility-risk.
“Fresenius Recalls DELFLEX Dialysis Solution Due to Sterility Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32908-fresenius-recalls-delflex-dialysis-solution-due-to-sterility-risk. Based on FDA recall #D-0218-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0218-2024%22&limit=1).
Fresenius Medical Care Holdings, Inc. voluntarily recalled DELFLEX Peritoneal Dialysis Solution due to a lack of sterility assurance, according to the FDA on Dec. 28, 2023.
How to tell if you have it
Brand: Fresenius Medical Care
Product: DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Packaging: 6000mL bags
NDC: 49230-206-62
Part Number: 077-60621
Lot #: 23JK02010
Exp. Date: 1/31/2025
The hazard
The product poses a lack of sterility assurance hazard, according to the FDA.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls include Fresenius Bicarby Dialysate leaks (May 12, 2026), Fresenius 5008X Blood Tubing Set errors (May 11, 2026), and Fresenius Medical Care Bicarby Dialysate labeling issues (May 7, 2026). Similar product recalls include Fresenius Kabi 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and 1000mL Sodium Chloride Injection, all citing lack of sterility assurance on March 11, 2026.
How to tell if you have this one
Look for DELFLEX Peritoneal Dialysis Solution in Biofine containers with 1.5% Dextrose in 6000mL bags. Check for NDC 49230-206-62, Part Number 077-60621, and Lot # 23JK02010 with an expiration date of 1/31/2025.
Brand
Fresenius Medical Care
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Product Details
Verify if your bag matches NDC 49230-206-62, Part Number 077-60621, and Lot # 23JK02010.
Stop Using the Product
Do not use the solution if it matches the recalled lot numbers due to sterility risks.
Contact Your Healthcare Provider
Reach out to your doctor or dialysis center immediately for guidance on alternative treatment options.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 13 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0218-2024 (December 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0218-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.