CareFusion 303, Inc. recalls Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System…

Recall date

August 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2879-2016

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.

Why it was recalled

A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.