ICU Medical: 6.5" Smallbore Ext Set Recall Due to Incorrect Spin Collar
ICU Medical recalls 6.5" smallbore infusion sets with incorrect spin collars. These devices may cause improper connections during medical use. Affected units include specific lot numbers and model A1009-NS.
Lower-risk recall
The infusion sets were manufactured with an incorrect spin collar.
Contact the company
What happened, in plain English
ICU Medical is recalling 6.5-inch smallbore infusion sets that were manufactured with an incorrect spin collar. This could lead to improper connections during medical procedures, potentially causing complications for patients. Read more at govinfonow.com/recall/72036-icu-medical-6-5-smallbore-ext-set-recall-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/72036-icu-medical-6-5-smallbore-ext-set-recall-due-to · Updated August 28, 2026 · FDA enforcement record: FDA #Z-1342-2018
Cite this page
“ICU Medical: 6.5" Smallbore Ext Set Recall Due to Incorrect Spin Collar.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72036-icu-medical-6-5-smallbore-ext-set-recall-due-to. Based on FDA recall #Z-1342-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1342-2018%22&limit=1).
Why it’s dangerous
The incorrect spin collar may not function properly during medical procedures, leading to improper connections. This could cause issues with fluid administration or patient safety.
Who’s affected
Healthcare professionals using these infusion sets for patient care are most at risk. Patients receiving treatment with the recalled sets may face complications if the spin collar fails.
How to tell if you have this one
Check for the model number A1009-NS on the label. The product was sold with lot numbers 3474877 and 3481246, and includes 500 units per case.
- Brand
ICU Medical- Category
Medical device
All 6 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: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1342-2018 | 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. 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).; Lot numbers 3474877, UDI (01) 0 0887709 074578 (30) 500 (10)3474877; and Lot number 3481246, UDI (01) 0 0887709 074578 (30) 500 (10) 3481246. | 11,500 pouches |
| Z-1343-2018 | 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. 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).; Lot number 3533699, UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10) 3533699, and lot number 3549590, UDI (01) 0 0887709 09040 8 (17) 221001 (30) 01 (10) 3549590. | 550 pouches |
| Z-1344-2018 | 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. 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).; Lot number 3483247, UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3483247; lot number 3484722, UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3484722; and lot number 3489328, UDI (01) 0 0887709 08949 5 (17) 220701 (30) 01 (10) 3489328. | 250 pouches |
| Z-1345-2018 | 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. 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).; Lot number 3482848, UDI (01) 0 0887709 01806 8 (17) 220701 (30) 01 (10) 3482848; lot number 3511823, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3511823; lot number 3516092, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3516092; and lot number 3545075, UDI (01) 0 0887709 01806 8 (17) 221001 (30) 01 (10) 3545075. | 2,950 pouches |
| Z-1346-2018 | 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. 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).; Lot number 3549002, UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002. | 100 pouches |
| Z-1347-2018 | 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. 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).; Lot number 3422861, UDI (01) 0 0840619 09588 8 (17) 200301 (30) 01 (10) 3422861; lot number 3489493, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3489493; lot number 3498769, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498769; and lot number 3498773, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498773. | 7,600 pouches |
What to do — step by step
Check Product Label
Look for the model number A1009-NS and lot numbers 3474877 or 3481246 on the label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
FDA distribution: “Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, South Carolina, Texas.
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 #Z-1342-2018 (February 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1342-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 28, 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.