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CareFusion 303, Inc. recalls Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Recalled September 11, 2019 · FDA recall Z-2443-2019 · CareFusion 303
Hazard
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 · FDA Class II
Units
76 EtCO2 units
Sold at
US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
Description
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
Product
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Manufacturer(s)
CareFusion 303, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →