ICU Medical Inc recalls 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake
ICU Medical recalls 0.9% Sodium Chloride Irrigation bottles due to confirmed particulate matter in some units. Affected lots expire April 2023; check NDC 0990-7138-09 for details.
Use caution until it’s fixed
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Contact the company & request your remedy
What happened, in plain English
ICU Medical is recalling 0.9% Sodium Chloride Irrigation bottles that may contain particulate matter. This could cause serious injury if particles enter the bloodstream during medical use. The recall follows one confirmed customer report of particulate matter in two bottles. Read more at govinfonow.com/recall/36492-icu-medical-0-9-sodium-chloride-irrigation-recall-particulate-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/36492-icu-medical-0-9-sodium-chloride-irrigation-recall-particulate-matter · Updated October 4, 2026 · FDA enforcement record: FDA #D-0313-2021
Cite this page
“ICU Medical 0.9% Sodium Chloride Irrigation Recall: Particulate Matter Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36492-icu-medical-0-9-sodium-chloride-irrigation-recall-particulate-matter. Based on FDA recall #D-0313-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0313-2021%22&limit=1).
Why it’s dangerous
Particulate matter in the irrigation solution could enter the bloodstream during medical use, potentially causing serious injury. This risk was confirmed in one customer report where particulate matter was found in two bottles before use.
Who’s affected
Healthcare professionals using these bottles for medical irrigation. Patients receiving IV treatments with the recalled bottles are at risk if particles enter the bloodstream.
How to tell if you have this one
Check for the NDC code 0990-7138-09 and lots 16-808-4B, 16-803-4B, or 16-809-4B. The bottles expire April 1, 2023 and are labeled as Rx only for ICU use.
- Brand
ICU Medical- Category
Drug
What to do — step by step
Check Bottle Details
Verify the NDC code 0990-7138-09 and lot numbers 16-808-4B, 16-803-4B, or 16-809-4B on the bottle.
Questions people ask
Why is this product being recalled?
ICU Medical recalled these bottles after one confirmed customer report of particulate matter in two units before use.
How can I check if I have the recalled product?
Look for the NDC code 0990-7138-09 and lot numbers 16-808-4B, 16-803-4B, or 16-809-4B on the bottle.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
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-0313-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall D-0313-2021 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-0313-2021 (March 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0313-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.