ICU Medical Inc recalls 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC
ICU Medical recalls 250mL 0.9% Sodium Chloride Injection (NDC 0409-7983-25) due to particulate matter risk. Affected lots expire May 2020.
Stop using this now
Presence of Particulate Matter.
Contact the company & request your remedy
What happened, in plain English
ICU Medical is recalling 250mL 0.9% Sodium Chloride Injection products that may contain particulate matter. This could cause serious injury if injected into a patient. Read more at govinfonow.com/recall/37779-icu-medical-0-9-sodium-chloride-injection-recall-particulate-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/37779-icu-medical-0-9-sodium-chloride-injection-recall-particulate-matter · Updated October 5, 2026 · FDA enforcement record: FDA #D-0350-2020
Cite this page
“ICU Medical 0.9% Sodium Chloride Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37779-icu-medical-0-9-sodium-chloride-injection-recall-particulate-matter. Based on FDA recall #D-0350-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0350-2020%22&limit=1).
Why it’s dangerous
Particulate matter in the injection solution can enter the bloodstream during administration. This may cause blockages, infections, or other serious complications in patients.
Who’s affected
Healthcare professionals who use this injection for medical treatments. Patients receiving this medication are at risk if the product is used without proper quality checks.
How to tell if you have this one
Check for the product name '0.9% Sodium Chloride Injection, USP, 250 mL VisIV Container' with NDC 0409-7983-25 and lot number 95-101-C6 expiring May 2020.
- Brand
ICU Medical- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0349-2020 | LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03; Lot: 84-603-FW Exp. 01 DEC 2019 | 389,808 bags |
| D-0350-2020 | 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25; Lot: 95-101-C6 Exp. 01 MAY 2020 | 58,464 bags |
What to do — step by step
Stop Using Now
Immediately discard any affected product as it may contain harmful particles that could cause serious injury.
Questions people ask
Is this product safe to use?
No, the product may contain particulate matter that can cause serious injury if injected.
What should I do if I have this product?
Discard it immediately and contact ICU Medical for further instructions.
When was this product manufactured?
The affected lot was produced in 2019 and expires May 2020.
Contact ICU Medical
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall D-0350-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall D-0350-2020 from ICU Medical. 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-0350-2020 (October 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0350-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.