FDA-Device2019-09-11Class II
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
CareFusion 303, Inc.
Hazard
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
Sold states
US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
Affected count
76 EtCO2 units
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2443-2019Don't want to check this manually?
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