Device Recall Alaris Pump Module

All products manufactured or serviced in the time period October 2011 through June 2015.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. || The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.

General Hospital and Personal Use Devices

2

No

US and Canada

Alaris Pump Module model 8100

Model 8100; Lot/Serial numbers-various

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.

Alaris Pump Module Model 8100 (formerly Medley Pump Module) || 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.

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.