ICU Medical Recalls 7-inch Smallbore Infusion Sets with Incorrect Spin Collar
ICU Medical is recalling 2,950 sterile 7-inch smallbore infusion sets because they were manufactured with an incorrect spin collar. The affected lots 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, but the source text does not report any hospitalizations, injuries, or deaths. The defect is a manufacturing error (incorrect spin collar) without explicit reports of harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ICU Medical, Inc. is recalling 2,950 pouches of 7-inch Smallbore Extension Sets with MicroClave, Clave T-Connector, Clamp, and Rotating Luer (Item B9900-629). The recall is due to the infusion sets being manufactured with an incorrect spin collar. The affected product is a single-use, sterile, non-pyrogenic device used to administer fluids to a patient's vascular system.
The recall covers four specific lot numbers: 3482848, 3511823, 3516092, and 3545075. These 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 providers and consumers should check their inventory for the specific lot numbers and UDI codes listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- 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…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 2,950
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 (8)
- 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.
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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