ICU Medical Recalls Smallbore Extension Sets with Incorrect Spin Collars
ICU Medical is recalling 11,500 smallbore extension sets manufactured with incorrect spin collars. The affected units were distributed in the US, Canada, and Japan.
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. The source text does not report any illnesses, injuries, or deaths, and the defect is a manufacturing error (incorrect spin collar) without explicit mention of high-risk pathogens or severe structural failure leading to immediate harm.
Plain-English summary
ICU Medical, Inc. is recalling 11,500 pouches of 6.5-inch (17 cm) Smallbore Extension Sets with Removable MicroClave Clear, NanoClave T-Connector, Clamp, and Rotating Luer. The specific item number is A1009-NS. These are single-use, sterile, non-pyrogenic intravascular administration sets used to provide access for the administration of fluids from a container to a patient's vascular system.
The recall was initiated because the infusion sets were manufactured with an incorrect spin collar. The affected products are identified by Lot numbers 3474877 and 3481246.
The affected units were distributed worldwide, including nationwide in the United States to the states of Arizona, California, Colorado, Florida, South Carolina, and Texas, as well as to Canada and Japan. Consumers and healthcare providers should stop using the affected products and contact ICU Medical for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 11,500
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 (4)
- 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.
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
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