CareFusion Recalls SmartSite Extension Sets Due to Disconnection and Leakage
CareFusion is recalling SmartSite Extension Sets because they may disconnect or leak. The recall affects 21,000 units distributed in the US and Canada.
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/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 without reported injury.
Plain-English summary
CareFusion 303, Inc. is recalling the SmartSite Extension Set, Model No. 20029E. This medical device is used to administer fluids and medications through a needle or catheter inserted into a patient's artery or vein.
The recall is being conducted due to disconnection and leakage issues with the product. A total of 21,000 units are affected, specifically those with Lot Nos. 15015769, 15035412, and 15045950. These units were distributed nationwide in the United States and in Canada.
Healthcare providers and consumers should stop using the affected SmartSite Extension Sets and contact CareFusion for further instructions or a replacement.
The recalled product
- Product
- SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- Affected units
- 21,000
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. 15015769
- 15035412
- 15045950.
Distribution
Distributed nationwide across the United States.
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