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Recall Observatory FDA recall evidence

Device product

Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system

Z-2721-2020

June 30, 2020

Class I

Product summary

Firm
CareFusion 303, Inc.
Event
Event 85691
Status
Terminated
Classification
Class I
Quantity
38982
Official record key
device-enforcement:Z-2721-2020

Official wording

Reason: 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.

Code information: During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.