ICU Medical Recalls Smallbore IV Set Due to Incorrect Filter Assembly
ICU Medical recalls 60" smallbore IV sets with incorrect 1.2 micron filter assembly. This could lead to improper fluid filtration during medical use. Affected units have model MC330174 and lot number 4799374.
Lower-risk recall
Due to the incorrect filter assembly.
Contact the company
What happened, in plain English
ICU Medical is recalling a specific smallbore IV set that has an incorrect filter assembly. This could cause improper fluid filtration during medical procedures, potentially leading to health risks for patients. Read more at govinfonow.com/recall/63727-icu-medical-recalls-smallbore-iv-set-due-to-incorrect-filter.
Source Summary by GovInfoNow · govinfonow.com/recall/63727-icu-medical-recalls-smallbore-iv-set-due-to-incorrect-filter · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0956-2021
Cite this page
“ICU Medical Recalls Smallbore IV Set Due to Incorrect Filter Assembly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63727-icu-medical-recalls-smallbore-iv-set-due-to-incorrect-filter. Based on FDA recall #Z-0956-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0956-2021%22&limit=1).
Why it’s dangerous
The filter assembly in the IV set is incorrect, which could lead to improper filtration of fluids. This might cause contaminants to enter the patient's bloodstream during intravenous administration.
Who’s affected
Healthcare professionals using the IV set for patient care are most at risk. Patients receiving treatment with this specific model may be affected if the filter assembly is incorrect.
How to tell if you have this one
Check for the model number MC330174 on the product label. The lot number 4799374 is associated with this recall. This product was sold with a specific size (60 inches) and filter specifications.
- Brand
ICU Medical- Product
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174- Category
Medical device
All 4 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 II- Status
Terminated- Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.
| Recall number | Product, codes & lots |
|---|---|
| Z-0955-2021 | 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).; Model List Number: B2209 UDI: (01)10887709085439(17)250401(30)50(10)4794177 Lot Number: 4794177 |
| Z-0956-2021 | 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).; Model List Number: MC330174 UDI: (01)10887709079974(17)250401(30)50(10)4799374 Lot Number: 4799374 |
| Z-0957-2021 | 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).; Model List Number: Z3532 UDI: (01)10887709033174(17)250401(30)50(10)4795091 Lot Number: 4795091 |
| Z-0958-2021 | 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).; Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428 |
What to do — step by step
Check Product Label
Look for the model number MC330174 and lot number 4799374 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 18 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, New Jersey, New York, North Carolina, Tennessee, Texas, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 2.6 years 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-0956-2021 (December 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0956-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.