CareFusion 303, Inc. recalls Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
- Recall date
- July 1, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2443-2019
- FDA classification
- Class II
- Brand / firm
- CareFusion 303, Inc.
- Sold / distributed
- US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
Why it was recalled
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
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