CareFusion Recalls SmartSite Infusion Sets Due to Tubing Separation Risk
CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the tubing sleeve may separate below the drip chamber.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (tubing separation) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048. The recall involves 15,860 units of the intravascular administration set.
The recall is being conducted because there is a potential for separation at the tubing sleeve below the drip chamber. This defect could compromise the integrity of the infusion set during use.
The affected products were distributed nationwide in the US, specifically in Pennsylvania, Oklahoma, Texas, Florida, North Carolina, California, Indiana, and Wisconsin. The recall covers Lot Numbers 13015883 and 13025342. Healthcare facilities and consumers should stop using these specific lots and contact CareFusion for further instructions.
The recalled product
- Product
- SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Set
- Affected units
- 15,860
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 Numbers 13015883 and 13025342.
Distribution
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