Fresenius Recalls Sodium Chloride Injection Due to Sterility Risk
Fresenius Medical Care recalls 1000 mL bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.
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Lack of Assurance of Sterility
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What happened, in plain English
Fresenius Medical Care Renal Therapies Group, LLC is recalling specific lots of 0.9% Sodium Chloride Injection, USP, 1000 mL bags. The recall is necessary because there is a lack of assurance that the product remains sterile during manufacturing or distribution. This issue affects approximately 25,356 units distributed throughout the United States. Read more at govinfonow.com/recall/41096-fresenius-recalls-sodium-chloride-injection-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41096-fresenius-recalls-sodium-chloride-injection-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0827-2018
Cite this page
“Fresenius Recalls Sodium Chloride Injection Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41096-fresenius-recalls-sodium-chloride-injection-due-to-sterility-risk. Based on FDA recall #D-0827-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0827-2018%22&limit=1).
Why it’s dangerous
The primary hazard is a lack of assurance of sterility, meaning the solution may contain microorganisms. Using non-sterile injectable fluids can lead to serious infections or other adverse health effects in patients.
Who’s affected
Patients and healthcare providers who have received or are using the recalled 0.9% Sodium Chloride Injection bags. Individuals relying on sterile saline for medical treatments are at risk of exposure to non-sterile product.
How to tell if you have this one
Check for 0.9% Sodium Chloride Injection, USP, 1000 mL bags marked Rx Only. Look for Lot # 17LU05005 with an expiration date of 09/18. The product has NDC 49230-0300-10 and Part Number 060-10109.
- Brand
Fresenius Medical Care- Category
Drug
What to do — step by step
Stop using the product
Do not use any bags matching the recalled lot number due to sterility concerns.
Contact your provider
Reach out to your healthcare provider or pharmacist for guidance on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0827-2018 (November 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0827-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.