ICU Medical 1000mL IV Fluid Recall: Particulate Matter Risk
ICU Medical recalls 1000mL 0.9% Sodium Chloride Injection due to possible stainless steel particles. Affected units have NDC# 0409-7983-09 and lot 61-841-FW expiring 01/01/2018.
Stop using this now
Presence of Particulate Matter; stainless steel
Contact the company
What happened, in plain English
ICU Medical is recalling 1000mL 0.9% Sodium Chloride Injection because it may contain stainless steel particles. This could cause serious injury if injected into a patient. The recall affects specific lots produced by Hospira in Lake Forest, Illinois. Read more at govinfonow.com/recall/41425-icu-medical-1000ml-iv-fluid-recall-particulate-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41425-icu-medical-1000ml-iv-fluid-recall-particulate-matter-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-1091-2017
Cite this page
“ICU Medical 1000mL IV Fluid Recall: Particulate Matter Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41425-icu-medical-1000ml-iv-fluid-recall-particulate-matter-risk. Based on FDA recall #D-1091-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1091-2017%22&limit=1).
Why it’s dangerous
The injection may contain stainless steel particles that could cause serious injury if accidentally injected into a patient. This is a known hazard in medical products where particles can enter the bloodstream.
Who’s affected
Healthcare facilities and patients using this IV fluid. Those with the specific lot number (61-841-FW) and expiration date (01/01/2018) are most at risk.
How to tell if you have this one
Check for the NDC code 0409-7983-09 and lot number 61-841-FW on the container. The product expires January 1, 2018.
- Brand
ICU Medical- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled 1000mL 0.9% Sodium Chloride Injection if you have the NDC# 0409-7983-09 and lot 61-841-FW.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 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-1091-2017 (July 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1091-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.