FDA (Devices) recall action 87470
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
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.
Tenacore LLC is recalling 474 Alaris Infusion Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, potentially causing infusion errors.
Tenacore LLC is recalling Alaris Infusion Pump 8100 bezels because they may crack or separate, potentially causing infusion errors.