FDA-Device2015-12-30Class II

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.

CareFusion 303, Inc.
Hazard

CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.

Sold states
Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.
Affected count
1,445,180 units
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0445-2016

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