CareFusion 303, Inc.

Lot No. 15015769, 15035412, 15045950.

General Hospital and Personal Use Devices

2

No

Distributed US (nationwide) and in Canada.

SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

The affected units have unique serial numbers for traceability.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CT, FL, IA, IL, MI, MO, NJ, NY, OH, SC, SD, and TX. and the country of Australia.

Alaris PC unit model 8015. || The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands.

Alaris Pump Module model 8100. || Subsequent product code: FPA || The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

Lot No. 14035485 14046894 14035458 14035457

General Hospital and Personal Use Devices

2

No

Distributed in the states of FL, NM, WA, WI, and TX.

SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A || 14035457 || 14035485 || 14046894 || 14035458

Lot No. 13085791

General Hospital and Personal Use Devices

2

No

USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI

SmartSite Extension Set, Model No. 20029E, intravascular administration set.