ICU Medical 100mL Sodium Chloride Injection Recall: Sterility Risk
ICU Medical recalls 100mL 0.9% Sodium Chloride Injection bags due to potential leakage compromising sterility. Affected lots expire MAR 2024.
Use caution until it’s fixed
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Contact the company
What happened, in plain English
ICU Medical is recalling 100mL 0.9% Sodium Chloride Injection bags that may leak and compromise sterility. This could lead to infections if used in medical settings. Read more at govinfonow.com/recall/34230-icu-medical-100ml-sodium-chloride-injection-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34230-icu-medical-100ml-sodium-chloride-injection-recall-sterility-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0062-2023
Cite this page
“ICU Medical 100mL Sodium Chloride Injection Recall: Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34230-icu-medical-100ml-sodium-chloride-injection-recall-sterility-risk. Based on FDA recall #D-0062-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0062-2023%22&limit=1).
Why it’s dangerous
The flexible bags may leak during use, which could contaminate the solution and cause infections. This is a sterility risk in medical settings where the solution is used directly for patient treatment.
Who’s affected
Healthcare professionals using these injections for medical treatments. Patients receiving IV fluids through this product are at risk if the bag leaks.
How to tell if you have this one
Check for the product name '0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag' with NDC 0990-7984-37. Lot number 5829936, expiring March 31, 2024.
- Brand
ICU Medical- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number (5829936) and expiration date (March 31, 2024) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 14 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0062-2023 (November 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0062-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.