The Recall Desk
HighFDA (Devices)·Z-0445-2016·Announced 2015-12-30

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.

What this means for you

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.

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · leakage

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