ICU Medical Recalls Smallbore Extension Sets Due to Incorrect Spin Collar
ICU Medical is recalling 100 pouches of 5-inch Smallbore Extension Sets because they were manufactured with an incorrect spin collar.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
ICU Medical, Inc. is recalling 100 pouches of 5-inch (13 cm) Smallbore Extension Sets with MicroClave, Clave T-Connector, Clamp, and Rotating Luer. The product is identified by Item B99066, Lot number 3549002, and UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002. The sets are sterile, single-use, non-pyrogenic devices intended for the administration of fluids to a patient's vascular system.
The recall was initiated because the infusion sets were manufactured with an incorrect spin collar. The agency has classified this recall as Class II.
The affected products were distributed nationwide in the United States to Arizona, California, Colorado, Florida, South Carolina, and Texas, as well as to Canada and Japan. Healthcare facilities and consumers should stop using the affected lots and contact ICU Medical for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number 3549002
- UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002.
Distribution
Part of a larger recall action
This product is one of 6 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighICU Medical Recalls Smallbore Extension Sets Due to Seal Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect
FDA (Devices) · 2020-10-28
- SevereICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls Smallbore Extension Sets Due to Manufacturing Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls Smallbore Pressure Infusion Extension Sets
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls Smallbore Trifuse Extension Sets Due to Seal Defect
FDA (Devices) · 2020-10-28