CareFusion 303, Inc.

Lot No. 12056016, 12057027, and 12107105.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

SmartSite Low Sorbing Infusion Set, Model No. 10015862 || The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

General Hospital and Personal Use Devices

2

No

US Nationwide Distribution

Alaris PC unit model 8015, Infusion pump. software version 9.17 || Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-US (nationwide) and the countries of Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan.

Alaris Syringe Pump, Model No. 8110. Delivers fluids. || Expansion of Affected Units: || BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

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General Hospital and Personal Use Devices

2

No

Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.

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.

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Anesthesiology Devices

2

No

US Distribution.

Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).