CareFusion Recalls SmartSite Infusion Sets Due to Disconnection and Leakage
CareFusion is recalling 7,440 SmartSite Low Sorbing Infusion Sets due to disconnection and leakage issues.
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 functional defect (disconnection and leakage) that poses a risk of harm to patients, but the source text does not report any specific 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 7,440 units of the SmartSite Low Sorbing Infusion Set, Model No. 10015862. The recall is due to disconnection and leakage issues with the product.
The affected units are distributed nationwide and include Lot No. 12056016, 12057027, and 12107105. These infusion sets are used to administer fluids and medications through a needle or catheter inserted into a patient's artery or vein.
The source text does not specify further instructions for consumers or healthcare providers regarding the recall.
The recalled product
- Product
- SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular…
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Set
- Hazard
- Affected units
- 7,440
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 (3)
- Lot No. 12056016
- 12057027
- and 12107105.
Distribution
Distributed nationwide across the United States.
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