CareFusion Recalls Alaris Pump SmartSite Infusion Sets Due to Leakage Risk
CareFusion is recalling Alaris Pump SmartSite Infusion Sets because disconnection and leakage may occur during infusion.
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 risk of harm (leakage/disconnection) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. This medical device is used to administer fluid and medications through a needle or catheter inserted into a patient's artery or vein.
The recall is being conducted because disconnection and leakage may occur during infusion. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Approximately 1,445,180 units were distributed nationwide in the United States, as well as in Canada, Australia, and New Zealand. Consumers and healthcare providers should stop using the affected infusion sets and contact CareFusion for instructions on how to proceed.
The recalled product
- Product
- Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. 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 Set
- Hazard
- Affected units
- 1,445,180
Distribution
Distributed nationwide across the United States.
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