CareFusion Recalls SmartSite Infusion Sets Due to Tubing Assembly Error
CareFusion is recalling 480 units of SmartSite Low Sorbing Infusion Sets because they were not assembled with low-sorbing tubing.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CareFusion 303, Inc. is recalling 480 units of the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer, Model No. 24301-0007T. The recall was initiated because the affected infusion sets were not assembled with low-sorbing tubing as intended.
The affected products are used to administer fluids and medications through a needle or catheter inserted into a patient's artery or vein. The recall covers specific lot numbers: 13046215, 13046641, 13056285, 13056577, and 13075931.
These products were distributed in the United States to California, Wyoming, Ohio, Utah, and Massachusetts. Healthcare facilities and consumers should stop using the affected infusion sets and contact CareFusion for further instructions.
The recalled product
- Product
- SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 480
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 (1)
- Lot No: 13046215 13046641 13056285 13056577 13075931
Distribution
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