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