Medley ETCO2 Module (Includes Accessories), Model 8300

• • Terminated Z-2443-2019 FDA Class II ·initiated 1 Jul 2019

  Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2

• • Terminated Z-0455-2016 FDA Class II ·initiated 12 Nov 2015

  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.

510(k) Number

K031741 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K043299 Active Cleared 10 Dec 2004

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