Recall – Respiratory monitoring systems may have incorrect calibration

Company: CareFusion 303, Inc.
Date of Enforcement Report: 9/11/2019
Class II

PRODUCT

Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933

  • Recall Number: Z-2443-2019

REASON

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

RECALLING FIRM/MANUFACTURER

CareFusion 303, Inc. on 7/1/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

76 EtCO2 units

DISTRIBUTION

US Nationwide and Australia

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