FDAFDA · Food and drugs·Recall number Z-2717-2020
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Published August 12, 2020 · Recall initiated: June 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- 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
- Lot
- During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. US and OUS serial numbers:
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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