ICU Medical recalls IV sets with metallic burr in stopcocks
ICU Medical recalls specific IV sets that may contain a metallic burr in stopcocks, which could cause injury during use. Affected products include various 15-drop admin sets with 3-way stopcocks.
Use caution until it’s fixed
ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
Contact the company
What happened, in plain English
ICU Medical is recalling certain IV sets that may have a metallic burr in the stopcocks. This could cause injury if the burr punctures the vein during use. Affected products include specific models with 3-way stopcocks and certain lot numbers. Read more at govinfonow.com/recall/73092-icu-medical-recalls-iv-sets-with-metallic-burr-in-stopcocks.
Source Summary by GovInfoNow · govinfonow.com/recall/73092-icu-medical-recalls-iv-sets-with-metallic-burr-in-stopcocks · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0106-2018
Cite this page
“ICU Medical recalls IV sets with metallic burr in stopcocks.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73092-icu-medical-recalls-iv-sets-with-metallic-burr-in-stopcocks. Based on FDA recall #Z-0106-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0106-2018%22&limit=1).
Why it’s dangerous
The stopcocks in these IV sets may contain a metallic burr that can puncture the vein during use. This could lead to injury if the burr causes a tear in the vein wall.
Who’s affected
Healthcare professionals and patients using the recalled IV sets are most at risk. The recall affects specific models sold for intravenous fluid administration.
How to tell if you have this one
Check for the product names and item numbers listed in the recall notice. Affected models include 15-drop admin sets with 3-way stopcocks and specific lot numbers like 3458321.
- Brand
ICU Medical- Category
Medical device
What to do — step by step
Check Product Details
Identify the item number and lot number on the IV set packaging to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 14 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 #Z-0106-2018 (August 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0106-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.