PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 30, 2015 Initiated: November 5, 2015 #Z-0445-2016

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
1,445,180 units
Distribution
Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by CareFusion 303, Inc.. Units affected: 1,445,180 units.
Why was this product recalled?
CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0445-2016.