CareFusion 303, Inc. recalls Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional i…

Recall date

November 12, 2015

Source

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

Recall number

Z-0455-2016

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

US Distribution.

Why it was recalled

CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2.

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