FDA (Devices) recall action 85691
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.
CareFusion is recalling Alaris Auto ID Modules because cleaning agents may damage connectors, causing infusion interruptions and therapy stops.
CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because cleaning agents may damage connectors, causing therapy interruptions.
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 infusion pumps because cleaning agents may damage connectors, potentially interrupting therapy or monitoring.
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 infusion pumps because cleaning agents may damage connectors, causing therapy interruptions.
CareFusion 303, Inc. is recalling Alaris SpO2 Modules because cleaning agents may damage connectors, causing infusion or monitoring interruptions.
CareFusion 303, Inc. is recalling 83,532 Alaris PCA Module Model 8120 units because cleaning agents may damage connectors, causing therapy interruptions.
CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.