FDA-Device2020-08-12Class I
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
CareFusion 303, Inc.
Hazard
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
Sold states
Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH
Affected count
38982
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2721-2020Don't want to check this manually?
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